Trial Outcomes & Findings for Reducing Postoperative Opioids in Patients Undergoing Laparoscopic Hiatal Hernia (NCT NCT05953428)
NCT ID: NCT05953428
Last Updated: 2026-08-13
Results Overview
The difference in discharge opioid consumption in morphine milligram equivalents (MMEs) from postoperative day 1 through postoperative day 7 in patients in the Opioid Sparing Anesthesia (OSA) protocol vs. Opioid Based Anesthesia (OBA) protocol will be collected.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Postoperative day 1,2, 3, 4, 5, 6 and 7.
Results posted on
2026-08-13
Participant Flow
This trial enrolled patients within the Endeavor Health Evanston, Glenbrook, and Highland Park Hospitals between March 2024 and January 2026. All participants provided written informed consent prior to their participation in the study via an electronic consent form in REDCap. Informed consent was obtained after receiving permission from the general surgery team to recruit the patient, followed by a discussion of the study and consent form with research staff via telephone.
Two patients were withdrawn from the study following enrollment but prior to study group assignment. One patient was withdrawn prior to their surgery date because their procedure was scheduled at a hospital site not included in the original protocol. One patient was withdrawn due to a pharmacy drug error in which the study drug was not prepared correctly prior to their procedure.
Participant milestones
| Measure |
Opioid Sparing Anesthesia Protocol
The OSA protocol will include boluses of dexmedetomidine and ketamine at anesthesia induction, followed by a ketamine infusion that will continue until PACU discharge. Another bolus of ketamine will be administered upon surgical incision and another dexmedetomidine bolus will be given at surgical closure to reduce the use of opioids.
|
Opioid Based Anesthesia Protocol
The OBA group will be administered a saline infusion at the same rate of the ketamine infusion (only while in the PACU) up until PACU discharge so that surgeons, patients, and PACU nurses will be blinded. The OBA group will be administered fentanyl 100 mcg IV for anesthesia induction followed by 50 mcg IV boluses when heart rate or systolic blood pressure is 20% above baseline throughout the case.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
25
|
|
Overall Study
COMPLETED
|
23
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
History of liver (cirrhosis or hepatitis), kidney (chronic kidney disease), endocrine (diabetes, hyperthyroidism, or hypothyroidism), respiratory (asthma, COPD, or obstructive sleep apnea), neurological (peripheral or cervical neuropathy), or cardiac (hypertension, hypercholesterolemia, coronary artery disease, arrhythmia, heart failure, peripheral vascular disease).
Baseline characteristics by cohort
| Measure |
Opioid Sparing Anesthesia Protocol
n=23 Participants
The OSA protocol will include boluses of dexmedetomidine and ketamine at anesthesia induction, followed by a ketamine infusion that will continue until PACU discharge. Another bolus of ketamine will be administered upon surgical incision and another dexmedetomidine bolus will be given at surgical closure to reduce the use of opioids.
|
Opioid Based Anesthesia Protocol
n=25 Participants
The OBA group will be administered a saline infusion at the same rate of the ketamine infusion (only while in the PACU) up until PACU discharge so that surgeons, patients, and PACU nurses will be blinded. The OBA group will be administered fentanyl 100 mcg IV for anesthesia induction followed by 50 mcg IV boluses when heart rate or systolic blood pressure is 20% above baseline throughout the case.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 Years
STANDARD_DEVIATION 9 • n=1 Participants
|
67 Years
STANDARD_DEVIATION 9 • n=1 Participants
|
66 Years
STANDARD_DEVIATION 9 • n=1 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=1 Participants
|
18 Participants
n=1 Participants
|
35 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=1 Participants
|
7 Participants
n=1 Participants
|
13 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
22 Participants
n=1 Participants
|
24 Participants
n=1 Participants
|
46 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Race · Other/Unknown
|
1 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
|
Height
|
1.8 Meters
STANDARD_DEVIATION 0.2 • n=1 Participants
|
1.7 Meters
STANDARD_DEVIATION 0.1 • n=1 Participants
|
1.7 Meters
STANDARD_DEVIATION 0.2 • n=1 Participants
|
|
Weight
|
91.0 Kilograms
STANDARD_DEVIATION 19.6 • n=1 Participants
|
78.7 Kilograms
STANDARD_DEVIATION 17.1 • n=1 Participants
|
84.6 Kilograms
STANDARD_DEVIATION 19.2 • n=1 Participants
|
|
BMI
|
31.0 kg/m²
STANDARD_DEVIATION 5.6 • n=1 Participants
|
28.7 kg/m²
STANDARD_DEVIATION 4.7 • n=1 Participants
|
29.8 kg/m²
STANDARD_DEVIATION 5.2 • n=1 Participants
|
|
ASA Status
2
|
10 Participants
n=1 Participants
|
13 Participants
n=1 Participants
|
23 Participants
n=1 Participants
|
|
ASA Status
3
|
13 Participants
n=1 Participants
|
12 Participants
n=1 Participants
|
25 Participants
n=1 Participants
|
|
System Comorbidities (Yes)
Liver (Yes)
|
0 Participants
n=1 Participants • History of liver (cirrhosis or hepatitis), kidney (chronic kidney disease), endocrine (diabetes, hyperthyroidism, or hypothyroidism), respiratory (asthma, COPD, or obstructive sleep apnea), neurological (peripheral or cervical neuropathy), or cardiac (hypertension, hypercholesterolemia, coronary artery disease, arrhythmia, heart failure, peripheral vascular disease).
|
1 Participants
n=1 Participants • History of liver (cirrhosis or hepatitis), kidney (chronic kidney disease), endocrine (diabetes, hyperthyroidism, or hypothyroidism), respiratory (asthma, COPD, or obstructive sleep apnea), neurological (peripheral or cervical neuropathy), or cardiac (hypertension, hypercholesterolemia, coronary artery disease, arrhythmia, heart failure, peripheral vascular disease).
|
1 Participants
n=1 Participants • History of liver (cirrhosis or hepatitis), kidney (chronic kidney disease), endocrine (diabetes, hyperthyroidism, or hypothyroidism), respiratory (asthma, COPD, or obstructive sleep apnea), neurological (peripheral or cervical neuropathy), or cardiac (hypertension, hypercholesterolemia, coronary artery disease, arrhythmia, heart failure, peripheral vascular disease).
|
|
System Comorbidities (Yes)
Kidney (Yes)
|
1 Participants
n=1 Participants • History of liver (cirrhosis or hepatitis), kidney (chronic kidney disease), endocrine (diabetes, hyperthyroidism, or hypothyroidism), respiratory (asthma, COPD, or obstructive sleep apnea), neurological (peripheral or cervical neuropathy), or cardiac (hypertension, hypercholesterolemia, coronary artery disease, arrhythmia, heart failure, peripheral vascular disease).
|
0 Participants
n=1 Participants • History of liver (cirrhosis or hepatitis), kidney (chronic kidney disease), endocrine (diabetes, hyperthyroidism, or hypothyroidism), respiratory (asthma, COPD, or obstructive sleep apnea), neurological (peripheral or cervical neuropathy), or cardiac (hypertension, hypercholesterolemia, coronary artery disease, arrhythmia, heart failure, peripheral vascular disease).
|
1 Participants
n=1 Participants • History of liver (cirrhosis or hepatitis), kidney (chronic kidney disease), endocrine (diabetes, hyperthyroidism, or hypothyroidism), respiratory (asthma, COPD, or obstructive sleep apnea), neurological (peripheral or cervical neuropathy), or cardiac (hypertension, hypercholesterolemia, coronary artery disease, arrhythmia, heart failure, peripheral vascular disease).
|
|
System Comorbidities (Yes)
Endocrine (Yes)
|
8 Participants
n=1 Participants • History of liver (cirrhosis or hepatitis), kidney (chronic kidney disease), endocrine (diabetes, hyperthyroidism, or hypothyroidism), respiratory (asthma, COPD, or obstructive sleep apnea), neurological (peripheral or cervical neuropathy), or cardiac (hypertension, hypercholesterolemia, coronary artery disease, arrhythmia, heart failure, peripheral vascular disease).
|
5 Participants
n=1 Participants • History of liver (cirrhosis or hepatitis), kidney (chronic kidney disease), endocrine (diabetes, hyperthyroidism, or hypothyroidism), respiratory (asthma, COPD, or obstructive sleep apnea), neurological (peripheral or cervical neuropathy), or cardiac (hypertension, hypercholesterolemia, coronary artery disease, arrhythmia, heart failure, peripheral vascular disease).
|
13 Participants
n=1 Participants • History of liver (cirrhosis or hepatitis), kidney (chronic kidney disease), endocrine (diabetes, hyperthyroidism, or hypothyroidism), respiratory (asthma, COPD, or obstructive sleep apnea), neurological (peripheral or cervical neuropathy), or cardiac (hypertension, hypercholesterolemia, coronary artery disease, arrhythmia, heart failure, peripheral vascular disease).
|
|
System Comorbidities (Yes)
Respiratory (Yes)
|
9 Participants
n=1 Participants • History of liver (cirrhosis or hepatitis), kidney (chronic kidney disease), endocrine (diabetes, hyperthyroidism, or hypothyroidism), respiratory (asthma, COPD, or obstructive sleep apnea), neurological (peripheral or cervical neuropathy), or cardiac (hypertension, hypercholesterolemia, coronary artery disease, arrhythmia, heart failure, peripheral vascular disease).
|
10 Participants
n=1 Participants • History of liver (cirrhosis or hepatitis), kidney (chronic kidney disease), endocrine (diabetes, hyperthyroidism, or hypothyroidism), respiratory (asthma, COPD, or obstructive sleep apnea), neurological (peripheral or cervical neuropathy), or cardiac (hypertension, hypercholesterolemia, coronary artery disease, arrhythmia, heart failure, peripheral vascular disease).
|
19 Participants
n=1 Participants • History of liver (cirrhosis or hepatitis), kidney (chronic kidney disease), endocrine (diabetes, hyperthyroidism, or hypothyroidism), respiratory (asthma, COPD, or obstructive sleep apnea), neurological (peripheral or cervical neuropathy), or cardiac (hypertension, hypercholesterolemia, coronary artery disease, arrhythmia, heart failure, peripheral vascular disease).
|
|
System Comorbidities (Yes)
Neurological (Yes)
|
0 Participants
n=1 Participants • History of liver (cirrhosis or hepatitis), kidney (chronic kidney disease), endocrine (diabetes, hyperthyroidism, or hypothyroidism), respiratory (asthma, COPD, or obstructive sleep apnea), neurological (peripheral or cervical neuropathy), or cardiac (hypertension, hypercholesterolemia, coronary artery disease, arrhythmia, heart failure, peripheral vascular disease).
|
1 Participants
n=1 Participants • History of liver (cirrhosis or hepatitis), kidney (chronic kidney disease), endocrine (diabetes, hyperthyroidism, or hypothyroidism), respiratory (asthma, COPD, or obstructive sleep apnea), neurological (peripheral or cervical neuropathy), or cardiac (hypertension, hypercholesterolemia, coronary artery disease, arrhythmia, heart failure, peripheral vascular disease).
|
1 Participants
n=1 Participants • History of liver (cirrhosis or hepatitis), kidney (chronic kidney disease), endocrine (diabetes, hyperthyroidism, or hypothyroidism), respiratory (asthma, COPD, or obstructive sleep apnea), neurological (peripheral or cervical neuropathy), or cardiac (hypertension, hypercholesterolemia, coronary artery disease, arrhythmia, heart failure, peripheral vascular disease).
|
|
System Comorbidities (Yes)
Cardiac (Yes)
|
18 Participants
n=1 Participants • History of liver (cirrhosis or hepatitis), kidney (chronic kidney disease), endocrine (diabetes, hyperthyroidism, or hypothyroidism), respiratory (asthma, COPD, or obstructive sleep apnea), neurological (peripheral or cervical neuropathy), or cardiac (hypertension, hypercholesterolemia, coronary artery disease, arrhythmia, heart failure, peripheral vascular disease).
|
17 Participants
n=1 Participants • History of liver (cirrhosis or hepatitis), kidney (chronic kidney disease), endocrine (diabetes, hyperthyroidism, or hypothyroidism), respiratory (asthma, COPD, or obstructive sleep apnea), neurological (peripheral or cervical neuropathy), or cardiac (hypertension, hypercholesterolemia, coronary artery disease, arrhythmia, heart failure, peripheral vascular disease).
|
35 Participants
n=1 Participants • History of liver (cirrhosis or hepatitis), kidney (chronic kidney disease), endocrine (diabetes, hyperthyroidism, or hypothyroidism), respiratory (asthma, COPD, or obstructive sleep apnea), neurological (peripheral or cervical neuropathy), or cardiac (hypertension, hypercholesterolemia, coronary artery disease, arrhythmia, heart failure, peripheral vascular disease).
|
|
Prescription Medications (Yes)
|
22 Participants
n=1 Participants
|
25 Participants
n=1 Participants
|
47 Participants
n=1 Participants
|
|
Prior Abdominal Surgery (Yes)
|
11 Participants
n=1 Participants
|
10 Participants
n=1 Participants
|
21 Participants
n=1 Participants
|
|
History of Alcohol Use (Yes)
|
5 Participants
n=1 Participants
|
7 Participants
n=1 Participants
|
12 Participants
n=1 Participants
|
|
History of Tobacco Use (Yes)
|
7 Participants
n=1 Participants
|
6 Participants
n=1 Participants
|
13 Participants
n=1 Participants
|
PRIMARY outcome
Timeframe: Postoperative day 1,2, 3, 4, 5, 6 and 7.The difference in discharge opioid consumption in morphine milligram equivalents (MMEs) from postoperative day 1 through postoperative day 7 in patients in the Opioid Sparing Anesthesia (OSA) protocol vs. Opioid Based Anesthesia (OBA) protocol will be collected.
Outcome measures
| Measure |
Opioid Sparing Anesthesia Protocol
n=23 Participants
The OSA protocol will include boluses of dexmedetomidine and ketamine at anesthesia induction, followed by a ketamine infusion that will continue until PACU discharge. Another bolus of ketamine will be administered upon surgical incision and another dexmedetomidine bolus will be given at surgical closure to reduce the use of opioids.
|
Opioid Based Anesthesia Protocol
n=25 Participants
The OBA group will be administered a saline infusion at the same rate of the ketamine infusion (only while in the PACU) up until PACU discharge so that surgeons, patients, and PACU nurses will be blinded. The OBA group will be administered fentanyl 100 mcg IV for anesthesia induction followed by 50 mcg IV boluses when heart rate or systolic blood pressure is 20% above baseline throughout the case.
|
|---|---|---|
|
The Difference in Discharge Opioid Consumption in Morphine Milligram Equivalents (MMEs)
Postoperative Day 1
|
4 MMEs
Interval 0.0 to 16.0
|
0 MMEs
Interval 0.0 to 10.0
|
|
The Difference in Discharge Opioid Consumption in Morphine Milligram Equivalents (MMEs)
Postoperative Day 2
|
10 MMEs
Interval 0.0 to 10.0
|
0 MMEs
Interval 0.0 to 10.0
|
|
The Difference in Discharge Opioid Consumption in Morphine Milligram Equivalents (MMEs)
Postoperative Day 3
|
0 MMEs
Interval 0.0 to 10.0
|
0 MMEs
Interval 0.0 to 5.0
|
|
The Difference in Discharge Opioid Consumption in Morphine Milligram Equivalents (MMEs)
Postoperative Day 4
|
0 MMEs
Interval 0.0 to 10.0
|
0 MMEs
Interval 0.0 to 0.0
|
|
The Difference in Discharge Opioid Consumption in Morphine Milligram Equivalents (MMEs)
Postoperative Day 5
|
0 MMEs
Interval 0.0 to 10.0
|
0 MMEs
Interval 0.0 to 0.0
|
|
The Difference in Discharge Opioid Consumption in Morphine Milligram Equivalents (MMEs)
Postoperative Day 6
|
0 MMEs
Interval 0.0 to 0.0
|
0 MMEs
Interval 0.0 to 0.0
|
|
The Difference in Discharge Opioid Consumption in Morphine Milligram Equivalents (MMEs)
Postoperative Day 7
|
0 MMEs
Interval 0.0 to 0.0
|
0 MMEs
Interval 0.0 to 0.0
|
|
The Difference in Discharge Opioid Consumption in Morphine Milligram Equivalents (MMEs)
Total Post-Discharge MME Consumption
|
15 MMEs
Interval 0.0 to 60.0
|
0 MMEs
Interval 0.0 to 23.0
|
SECONDARY outcome
Timeframe: Upon post-anesthesia care unit (PACU) arrival (within 2 hours after surgery), upon PACU discharge (4 hours after surgery), at hospital discharge, and on postoperative day 1, 2, 3, 4, 5, 6, and 7.Patients Visual Analogue Scale (VAS) pain scores in each group will be collected. Subjects will rate their pain level on a scale of 0-10 cm. Number "0" indicates no pain and number "10" indicates terrible pain.
Outcome measures
| Measure |
Opioid Sparing Anesthesia Protocol
n=23 Participants
The OSA protocol will include boluses of dexmedetomidine and ketamine at anesthesia induction, followed by a ketamine infusion that will continue until PACU discharge. Another bolus of ketamine will be administered upon surgical incision and another dexmedetomidine bolus will be given at surgical closure to reduce the use of opioids.
|
Opioid Based Anesthesia Protocol
n=25 Participants
The OBA group will be administered a saline infusion at the same rate of the ketamine infusion (only while in the PACU) up until PACU discharge so that surgeons, patients, and PACU nurses will be blinded. The OBA group will be administered fentanyl 100 mcg IV for anesthesia induction followed by 50 mcg IV boluses when heart rate or systolic blood pressure is 20% above baseline throughout the case.
|
|---|---|---|
|
Postoperative Visual Analogue Scale (VAS) Pain Scores
PACU Admission
|
3.7 cm
Standard Deviation 3.7
|
4.1 cm
Standard Deviation 3.4
|
|
Postoperative Visual Analogue Scale (VAS) Pain Scores
PACU Discharge
|
3.6 cm
Standard Deviation 1.6
|
3.5 cm
Standard Deviation 2.2
|
|
Postoperative Visual Analogue Scale (VAS) Pain Scores
Hospital Discharge
|
3.3 cm
Standard Deviation 2.1
|
3.0 cm
Standard Deviation 2.2
|
|
Postoperative Visual Analogue Scale (VAS) Pain Scores
Postoperative Day 1
|
5.2 cm
Standard Deviation 2.0
|
5.6 cm
Standard Deviation 2.1
|
|
Postoperative Visual Analogue Scale (VAS) Pain Scores
Postoperative Day 2
|
4.9 cm
Standard Deviation 1.9
|
5.1 cm
Standard Deviation 2.1
|
|
Postoperative Visual Analogue Scale (VAS) Pain Scores
Postoperative Day 3
|
4.2 cm
Standard Deviation 2.1
|
4.5 cm
Standard Deviation 2.3
|
|
Postoperative Visual Analogue Scale (VAS) Pain Scores
Postoperative Day 4
|
3.6 cm
Standard Deviation 2.6
|
3.2 cm
Standard Deviation 1.6
|
|
Postoperative Visual Analogue Scale (VAS) Pain Scores
Postoperative Day 5
|
3.3 cm
Standard Deviation 2.6
|
2.9 cm
Standard Deviation 2.0
|
|
Postoperative Visual Analogue Scale (VAS) Pain Scores
Postoperative Day 6
|
2.7 cm
Standard Deviation 2.6
|
2.0 cm
Standard Deviation 1.5
|
|
Postoperative Visual Analogue Scale (VAS) Pain Scores
Postoperative Day 7
|
2.3 cm
Standard Deviation 2.6
|
1.9 cm
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: From PACU admission until hospital discharge, up to 7 days after admissionTotal hospital opioid consumption (MMEs) in each group will be collected starting from the end of surgery (PACU admission) until hospital discharge or on postoperative day 7, whichever is first.
Outcome measures
| Measure |
Opioid Sparing Anesthesia Protocol
n=23 Participants
The OSA protocol will include boluses of dexmedetomidine and ketamine at anesthesia induction, followed by a ketamine infusion that will continue until PACU discharge. Another bolus of ketamine will be administered upon surgical incision and another dexmedetomidine bolus will be given at surgical closure to reduce the use of opioids.
|
Opioid Based Anesthesia Protocol
n=25 Participants
The OBA group will be administered a saline infusion at the same rate of the ketamine infusion (only while in the PACU) up until PACU discharge so that surgeons, patients, and PACU nurses will be blinded. The OBA group will be administered fentanyl 100 mcg IV for anesthesia induction followed by 50 mcg IV boluses when heart rate or systolic blood pressure is 20% above baseline throughout the case.
|
|---|---|---|
|
Postoperative Hospital Opioid Consumption (MMEs)
PACU
|
28 MME's
Interval 4.0 to 40.0
|
25 MME's
Interval 10.0 to 58.0
|
|
Postoperative Hospital Opioid Consumption (MMEs)
Postoperative Day 1
|
0 MME's
Interval 0.0 to 18.0
|
0 MME's
Interval 0.0 to 0.0
|
|
Postoperative Hospital Opioid Consumption (MMEs)
Postoperative Day 2
|
0 MME's
Interval 0.0 to 0.0
|
0 MME's
Interval 0.0 to 0.0
|
|
Postoperative Hospital Opioid Consumption (MMEs)
Postoperative Day 3
|
0 MME's
Interval 0.0 to 0.0
|
0 MME's
Interval 0.0 to 0.0
|
|
Postoperative Hospital Opioid Consumption (MMEs)
Postoperative Day 4
|
0 MME's
Interval 0.0 to 0.0
|
0 MME's
Interval 0.0 to 0.0
|
|
Postoperative Hospital Opioid Consumption (MMEs)
Postoperative Day 5
|
0 MME's
Interval 0.0 to 0.0
|
0 MME's
Interval 0.0 to 0.0
|
|
Postoperative Hospital Opioid Consumption (MMEs)
Postoperative Day 6
|
0 MME's
Interval 0.0 to 0.0
|
0 MME's
Interval 0.0 to 0.0
|
|
Postoperative Hospital Opioid Consumption (MMEs)
Postoperative Day 7
|
0 MME's
Interval 0.0 to 0.0
|
0 MME's
Interval 0.0 to 0.0
|
|
Postoperative Hospital Opioid Consumption (MMEs)
Total
|
30 MME's
Interval 8.0 to 66.0
|
40 MME's
Interval 13.0 to 68.0
|
SECONDARY outcome
Timeframe: from PACU admission until PACU dischargePost anesthesia care unit (PACU) length of stay (hours) in each group will be recorded.
Outcome measures
| Measure |
Opioid Sparing Anesthesia Protocol
n=23 Participants
The OSA protocol will include boluses of dexmedetomidine and ketamine at anesthesia induction, followed by a ketamine infusion that will continue until PACU discharge. Another bolus of ketamine will be administered upon surgical incision and another dexmedetomidine bolus will be given at surgical closure to reduce the use of opioids.
|
Opioid Based Anesthesia Protocol
n=25 Participants
The OBA group will be administered a saline infusion at the same rate of the ketamine infusion (only while in the PACU) up until PACU discharge so that surgeons, patients, and PACU nurses will be blinded. The OBA group will be administered fentanyl 100 mcg IV for anesthesia induction followed by 50 mcg IV boluses when heart rate or systolic blood pressure is 20% above baseline throughout the case.
|
|---|---|---|
|
Post Anesthesia Care Unit
|
2.1 hours
Interval 1.8 to 3.6
|
2.3 hours
Interval 1.6 to 3.8
|
SECONDARY outcome
Timeframe: from hospital admission for hernia surgery until hospital dischargeHospital length of stay (hours) in each group will be recorded.
Outcome measures
| Measure |
Opioid Sparing Anesthesia Protocol
n=23 Participants
The OSA protocol will include boluses of dexmedetomidine and ketamine at anesthesia induction, followed by a ketamine infusion that will continue until PACU discharge. Another bolus of ketamine will be administered upon surgical incision and another dexmedetomidine bolus will be given at surgical closure to reduce the use of opioids.
|
Opioid Based Anesthesia Protocol
n=25 Participants
The OBA group will be administered a saline infusion at the same rate of the ketamine infusion (only while in the PACU) up until PACU discharge so that surgeons, patients, and PACU nurses will be blinded. The OBA group will be administered fentanyl 100 mcg IV for anesthesia induction followed by 50 mcg IV boluses when heart rate or systolic blood pressure is 20% above baseline throughout the case.
|
|---|---|---|
|
Hospital Length of Stay
|
28 hours
Interval 8.0 to 31.0
|
24 hours
Interval 9.0 to 28.0
|
SECONDARY outcome
Timeframe: during post anesthesia care unit stay (up to 3 hours), postoperative Day 1, during hospital stay (up to 7 days)Incidence of post operative nausea and vomiting in each group will be recorded.
Outcome measures
| Measure |
Opioid Sparing Anesthesia Protocol
n=23 Participants
The OSA protocol will include boluses of dexmedetomidine and ketamine at anesthesia induction, followed by a ketamine infusion that will continue until PACU discharge. Another bolus of ketamine will be administered upon surgical incision and another dexmedetomidine bolus will be given at surgical closure to reduce the use of opioids.
|
Opioid Based Anesthesia Protocol
n=25 Participants
The OBA group will be administered a saline infusion at the same rate of the ketamine infusion (only while in the PACU) up until PACU discharge so that surgeons, patients, and PACU nurses will be blinded. The OBA group will be administered fentanyl 100 mcg IV for anesthesia induction followed by 50 mcg IV boluses when heart rate or systolic blood pressure is 20% above baseline throughout the case.
|
|---|---|---|
|
Incidence of Post Operative Nausea and Vomiting (PONV )
Incidence of PONV in PACU (Yes)
|
5 Participants
|
5 Participants
|
|
Incidence of Post Operative Nausea and Vomiting (PONV )
Incidence of PONV during hospital stay excluding PACU (Yes)
|
5 Participants
|
4 Participants
|
|
Incidence of Post Operative Nausea and Vomiting (PONV )
Incidence of PONV during overall hospital stay (Yes)
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: within 30 days of surgeryRate of rehospitalization will be recorded for each group up to 30 days after hiatal hernia surgery.
Outcome measures
| Measure |
Opioid Sparing Anesthesia Protocol
n=23 Participants
The OSA protocol will include boluses of dexmedetomidine and ketamine at anesthesia induction, followed by a ketamine infusion that will continue until PACU discharge. Another bolus of ketamine will be administered upon surgical incision and another dexmedetomidine bolus will be given at surgical closure to reduce the use of opioids.
|
Opioid Based Anesthesia Protocol
n=25 Participants
The OBA group will be administered a saline infusion at the same rate of the ketamine infusion (only while in the PACU) up until PACU discharge so that surgeons, patients, and PACU nurses will be blinded. The OBA group will be administered fentanyl 100 mcg IV for anesthesia induction followed by 50 mcg IV boluses when heart rate or systolic blood pressure is 20% above baseline throughout the case.
|
|---|---|---|
|
Rate of Rehospitalization
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: within 30 days of surgeryRate of reoperation will be recorded for each group up to 30 days after hiatal hernia surgery.
Outcome measures
| Measure |
Opioid Sparing Anesthesia Protocol
n=23 Participants
The OSA protocol will include boluses of dexmedetomidine and ketamine at anesthesia induction, followed by a ketamine infusion that will continue until PACU discharge. Another bolus of ketamine will be administered upon surgical incision and another dexmedetomidine bolus will be given at surgical closure to reduce the use of opioids.
|
Opioid Based Anesthesia Protocol
n=25 Participants
The OBA group will be administered a saline infusion at the same rate of the ketamine infusion (only while in the PACU) up until PACU discharge so that surgeons, patients, and PACU nurses will be blinded. The OBA group will be administered fentanyl 100 mcg IV for anesthesia induction followed by 50 mcg IV boluses when heart rate or systolic blood pressure is 20% above baseline throughout the case.
|
|---|---|---|
|
Rate of Reoperation
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: within 30 days of surgeryRate of emergency room visits will be recorded up to 30 days after hiatal hernia surgery.
Outcome measures
| Measure |
Opioid Sparing Anesthesia Protocol
n=23 Participants
The OSA protocol will include boluses of dexmedetomidine and ketamine at anesthesia induction, followed by a ketamine infusion that will continue until PACU discharge. Another bolus of ketamine will be administered upon surgical incision and another dexmedetomidine bolus will be given at surgical closure to reduce the use of opioids.
|
Opioid Based Anesthesia Protocol
n=25 Participants
The OBA group will be administered a saline infusion at the same rate of the ketamine infusion (only while in the PACU) up until PACU discharge so that surgeons, patients, and PACU nurses will be blinded. The OBA group will be administered fentanyl 100 mcg IV for anesthesia induction followed by 50 mcg IV boluses when heart rate or systolic blood pressure is 20% above baseline throughout the case.
|
|---|---|---|
|
Rate of Emergency Room Visit
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: within 30 minutes after surgerySurgeon satisfaction with surgical conditions using a 5-point Likert score will be collected after surgery. A scale from 1-5; 1=Very dissatisfied, 2=Somewhat dissatisfied, 3=Neutral, 4=Somewhat satisfied, 5=Very satisfied)
Outcome measures
| Measure |
Opioid Sparing Anesthesia Protocol
n=23 Participants
The OSA protocol will include boluses of dexmedetomidine and ketamine at anesthesia induction, followed by a ketamine infusion that will continue until PACU discharge. Another bolus of ketamine will be administered upon surgical incision and another dexmedetomidine bolus will be given at surgical closure to reduce the use of opioids.
|
Opioid Based Anesthesia Protocol
n=25 Participants
The OBA group will be administered a saline infusion at the same rate of the ketamine infusion (only while in the PACU) up until PACU discharge so that surgeons, patients, and PACU nurses will be blinded. The OBA group will be administered fentanyl 100 mcg IV for anesthesia induction followed by 50 mcg IV boluses when heart rate or systolic blood pressure is 20% above baseline throughout the case.
|
|---|---|---|
|
Surgeon Satisfaction With Surgical Conditions
1 (Very dissatisfied)
|
0 Participants
|
0 Participants
|
|
Surgeon Satisfaction With Surgical Conditions
2 (Somewhat dissatisfied)
|
0 Participants
|
0 Participants
|
|
Surgeon Satisfaction With Surgical Conditions
3 (Neutral)
|
0 Participants
|
0 Participants
|
|
Surgeon Satisfaction With Surgical Conditions
4 (Somewhat satisfied)
|
1 Participants
|
1 Participants
|
|
Surgeon Satisfaction With Surgical Conditions
5 (Very satisfied)
|
22 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Postoperative days 1, 2, 3, 4, 5, 6, 7.VAS Pain Severity was calculated for Postoperative Days 1-7. VAS scores of 0-3 were classified as mild, scores of 4-6 were classified as moderate, and scores of 7-10 were classified as severe.
Outcome measures
| Measure |
Opioid Sparing Anesthesia Protocol
n=23 Participants
The OSA protocol will include boluses of dexmedetomidine and ketamine at anesthesia induction, followed by a ketamine infusion that will continue until PACU discharge. Another bolus of ketamine will be administered upon surgical incision and another dexmedetomidine bolus will be given at surgical closure to reduce the use of opioids.
|
Opioid Based Anesthesia Protocol
n=25 Participants
The OBA group will be administered a saline infusion at the same rate of the ketamine infusion (only while in the PACU) up until PACU discharge so that surgeons, patients, and PACU nurses will be blinded. The OBA group will be administered fentanyl 100 mcg IV for anesthesia induction followed by 50 mcg IV boluses when heart rate or systolic blood pressure is 20% above baseline throughout the case.
|
|---|---|---|
|
VAS Pain Severity Postoperative Days 1-7
Postoperative Day 7 · Severe Pain (VAS = 7-10)
|
3 Participants
|
0 Participants
|
|
VAS Pain Severity Postoperative Days 1-7
Postoperative Day 1 · Mild Pain (VAS = 0-3)
|
4 Participants
|
5 Participants
|
|
VAS Pain Severity Postoperative Days 1-7
Postoperative Day 1 · Moderate Pain (VAS = 4-6)
|
13 Participants
|
10 Participants
|
|
VAS Pain Severity Postoperative Days 1-7
Postoperative Day 1 · Severe Pain (VAS = 7-10)
|
6 Participants
|
10 Participants
|
|
VAS Pain Severity Postoperative Days 1-7
Postoperative Day 2 · Mild Pain (VAS = 0-3)
|
5 Participants
|
6 Participants
|
|
VAS Pain Severity Postoperative Days 1-7
Postoperative Day 2 · Moderate Pain (VAS = 4-6)
|
12 Participants
|
11 Participants
|
|
VAS Pain Severity Postoperative Days 1-7
Postoperative Day 2 · Severe Pain (VAS = 7-10)
|
6 Participants
|
8 Participants
|
|
VAS Pain Severity Postoperative Days 1-7
Postoperative Day 3 · Mild Pain (VAS = 0-3)
|
10 Participants
|
8 Participants
|
|
VAS Pain Severity Postoperative Days 1-7
Postoperative Day 3 · Moderate Pain (VAS = 4-6)
|
7 Participants
|
11 Participants
|
|
VAS Pain Severity Postoperative Days 1-7
Postoperative Day 3 · Severe Pain (VAS = 7-10)
|
6 Participants
|
6 Participants
|
|
VAS Pain Severity Postoperative Days 1-7
Postoperative Day 4 · Mild Pain (VAS = 0-3)
|
12 Participants
|
13 Participants
|
|
VAS Pain Severity Postoperative Days 1-7
Postoperative Day 4 · Moderate Pain (VAS = 4-6)
|
5 Participants
|
12 Participants
|
|
VAS Pain Severity Postoperative Days 1-7
Postoperative Day 4 · Severe Pain (VAS = 7-10)
|
6 Participants
|
0 Participants
|
|
VAS Pain Severity Postoperative Days 1-7
Postoperative Day 5 · Mild Pain (VAS = 0-3)
|
11 Participants
|
16 Participants
|
|
VAS Pain Severity Postoperative Days 1-7
Postoperative Day 5 · Moderate Pain (VAS = 4-6)
|
6 Participants
|
7 Participants
|
|
VAS Pain Severity Postoperative Days 1-7
Postoperative Day 5 · Severe Pain (VAS = 7-10)
|
6 Participants
|
2 Participants
|
|
VAS Pain Severity Postoperative Days 1-7
Postoperative Day 6 · Mild Pain (VAS = 0-3)
|
15 Participants
|
19 Participants
|
|
VAS Pain Severity Postoperative Days 1-7
Postoperative Day 6 · Moderate Pain (VAS = 4-6)
|
4 Participants
|
6 Participants
|
|
VAS Pain Severity Postoperative Days 1-7
Postoperative Day 6 · Severe Pain (VAS = 7-10)
|
4 Participants
|
0 Participants
|
|
VAS Pain Severity Postoperative Days 1-7
Postoperative Day 7 · Mild Pain (VAS = 0-3)
|
19 Participants
|
19 Participants
|
|
VAS Pain Severity Postoperative Days 1-7
Postoperative Day 7 · Moderate Pain (VAS = 4-6)
|
1 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From hospital admission until hospital dischargeTotal Ketorolac dose administered intraoperatively and postoperatively until hospital discharge
Outcome measures
| Measure |
Opioid Sparing Anesthesia Protocol
n=23 Participants
The OSA protocol will include boluses of dexmedetomidine and ketamine at anesthesia induction, followed by a ketamine infusion that will continue until PACU discharge. Another bolus of ketamine will be administered upon surgical incision and another dexmedetomidine bolus will be given at surgical closure to reduce the use of opioids.
|
Opioid Based Anesthesia Protocol
n=25 Participants
The OBA group will be administered a saline infusion at the same rate of the ketamine infusion (only while in the PACU) up until PACU discharge so that surgeons, patients, and PACU nurses will be blinded. The OBA group will be administered fentanyl 100 mcg IV for anesthesia induction followed by 50 mcg IV boluses when heart rate or systolic blood pressure is 20% above baseline throughout the case.
|
|---|---|---|
|
Total Ketorolac Dose
|
28.7 mg
Standard Deviation 31.3
|
30.6 mg
Standard Deviation 21.0
|
Adverse Events
Opioid Sparing Anesthesia Protocol
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Opioid Based Anesthesia Protocol
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Opioid Sparing Anesthesia Protocol
n=23 participants at risk
The OSA protocol will include boluses of dexmedetomidine and ketamine at anesthesia induction, followed by a ketamine infusion that will continue until PACU discharge. Another bolus of ketamine will be administered upon surgical incision and another dexmedetomidine bolus will be given at surgical closure to reduce the use of opioids.
|
Opioid Based Anesthesia Protocol
n=25 participants at risk
The OBA group will be administered a saline infusion at the same rate of the ketamine infusion (only while in the PACU) up until PACU discharge so that surgeons, patients, and PACU nurses will be blinded. The OBA group will be administered fentanyl 100 mcg IV for anesthesia induction followed by 50 mcg IV boluses when heart rate or systolic blood pressure is 20% above baseline throughout the case.
|
|---|---|---|
|
Cardiac disorders
Emergency room admission > 24 hours due to heart failure
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up 30 days after date of surgery.
|
0.00%
0/25 • From enrollment until end of follow-up 30 days after date of surgery.
|
|
Infections and infestations
Hospital admission > 24 hours due to strep toxic shock syndrome
|
0.00%
0/23 • From enrollment until end of follow-up 30 days after date of surgery.
|
4.0%
1/25 • Number of events 1 • From enrollment until end of follow-up 30 days after date of surgery.
|
|
Injury, poisoning and procedural complications
Surgical complications requiring reoperation
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up 30 days after date of surgery.
|
0.00%
0/25 • From enrollment until end of follow-up 30 days after date of surgery.
|
Other adverse events
| Measure |
Opioid Sparing Anesthesia Protocol
n=23 participants at risk
The OSA protocol will include boluses of dexmedetomidine and ketamine at anesthesia induction, followed by a ketamine infusion that will continue until PACU discharge. Another bolus of ketamine will be administered upon surgical incision and another dexmedetomidine bolus will be given at surgical closure to reduce the use of opioids.
|
Opioid Based Anesthesia Protocol
n=25 participants at risk
The OBA group will be administered a saline infusion at the same rate of the ketamine infusion (only while in the PACU) up until PACU discharge so that surgeons, patients, and PACU nurses will be blinded. The OBA group will be administered fentanyl 100 mcg IV for anesthesia induction followed by 50 mcg IV boluses when heart rate or systolic blood pressure is 20% above baseline throughout the case.
|
|---|---|---|
|
Gastrointestinal disorders
Emergency room visit < 24 hours
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up 30 days after date of surgery.
|
0.00%
0/25 • From enrollment until end of follow-up 30 days after date of surgery.
|
|
Gastrointestinal disorders
Emergency room visit < 24 hours prior to study intervention taking place
|
0.00%
0/23 • From enrollment until end of follow-up 30 days after date of surgery.
|
4.0%
1/25 • Number of events 1 • From enrollment until end of follow-up 30 days after date of surgery.
|
|
Surgical and medical procedures
Planned unrelated surgical procedure during study follow-up period
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up 30 days after date of surgery.
|
0.00%
0/25 • From enrollment until end of follow-up 30 days after date of surgery.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place