Trial Outcomes & Findings for Intravenous Sedation Versus General Anesthesia in Patients Undergoing Minor Gynecologic Surgery (NCT NCT01890707)
NCT ID: NCT01890707
Last Updated: 2020-01-02
Results Overview
The patients self reported quality of recovery - 40 scores as completed 24 hours after the surgical procedure. 40 questions regarding the recovery of patients on a 1 poor-5 excellent scale. Total score on scale 40 (poor recovery)-200 (excellent recovery)
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
24 hours
Results posted on
2020-01-02
Participant Flow
Subjects will be recruited up to 14 days prior to surgery, by either the anesthesiology or the gynecology investigators. A preoperative anesthetic assessment will be completed. Once consent for the study has been obtained subjects will be randomly allocated into 2 groups, using a computer generated table of random numbers.
Participant milestones
| Measure |
Deep Sedation
Deep sedation
Deep Sedation: IV administration of Propofol,initial rate 100ug/kg/min, titrated to maintain BIS 65-75,Fentanyl,Ketamine,1mcg/kg,0.5mg/kg,additional 10mg increments for analgesia/movement.
|
General Anesthesia
Administration of general anesthesia. Propofol given IV, succinylcholine and rocuronium given IV and Sevoflurane via the endotracheal tube.
General Anesthesia: Administer: Fentanyl:1mcg/kg prior to induction, additional doses to maintain blood pressure and heart rate within 20% of preoperative values, Propofol:2mg/kg,succinylcholine, 0.5mg/kg,to be followed with Rocuronium if necessary,bolus: 0.4mg/kg, Sevoflurane and oxygen to be titrated to maintain BIS value of 40-60.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
8
|
|
Overall Study
COMPLETED
|
10
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Deep Sedation
Deep sedation
Deep Sedation: IV administration of Propofol,initial rate 100ug/kg/min, titrated to maintain BIS 65-75,Fentanyl,Ketamine,1mcg/kg,0.5mg/kg,additional 10mg increments for analgesia/movement.
|
General Anesthesia
Administration of general anesthesia. Propofol given IV, succinylcholine and rocuronium given IV and Sevoflurane via the endotracheal tube.
General Anesthesia: Administer: Fentanyl:1mcg/kg prior to induction, additional doses to maintain blood pressure and heart rate within 20% of preoperative values, Propofol:2mg/kg,succinylcholine, 0.5mg/kg,to be followed with Rocuronium if necessary,bolus: 0.4mg/kg, Sevoflurane and oxygen to be titrated to maintain BIS value of 40-60.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Deep Sedation
n=10 Participants
Deep sedation
Deep Sedation: IV administration of Propofol,initial rate 100ug/kg/min, titrated to maintain BIS 65-75,Fentanyl,Ketamine,1mcg/kg,0.5mg/kg,additional 10mg increments for analgesia/movement.
|
General Anesthesia
n=7 Participants
Administration of general anesthesia. Propofol given IV, succinylcholine and rocuronium given IV and Sevoflurane via the endotracheal tube.
General Anesthesia: Administer: Fentanyl:1mcg/kg prior to induction, additional doses to maintain blood pressure and heart rate within 20% of preoperative values, Propofol:2mg/kg,succinylcholine, 0.5mg/kg,to be followed with Rocuronium if necessary,bolus: 0.4mg/kg, Sevoflurane and oxygen to be titrated to maintain BIS value of 40-60.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
07 Participants
n=7 Participants
|
17 Participants
n=17 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
|
Age, Continuous
|
34.3 Years
STANDARD_DEVIATION 3.46 • n=10 Participants
|
35 Years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
34.5 Years
STANDARD_DEVIATION 5.4 • n=17 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=10 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
7 participants
n=7 Participants
|
17 participants
n=17 Participants
|
|
Height Inches
|
67.1 Inches
STANDARD_DEVIATION 2.3 • n=10 Participants
|
64 Inches
STANDARD_DEVIATION 1.85 • n=7 Participants
|
65.8 Inches
STANDARD_DEVIATION 2.16 • n=17 Participants
|
|
Kilogram Weight
|
73.9 Kilogram Weight
STANDARD_DEVIATION 13.8 • n=10 Participants
|
64.6 Kilogram Weight
STANDARD_DEVIATION 6.3 • n=7 Participants
|
70.07 Kilogram Weight
STANDARD_DEVIATION 12.23 • n=17 Participants
|
|
Gestational Age
|
19.17 Weeks
STANDARD_DEVIATION 2.13 • n=10 Participants
|
19.85 Weeks
STANDARD_DEVIATION 2.58 • n=7 Participants
|
19.45 Weeks
STANDARD_DEVIATION 2.35 • n=17 Participants
|
PRIMARY outcome
Timeframe: 24 hoursThe patients self reported quality of recovery - 40 scores as completed 24 hours after the surgical procedure. 40 questions regarding the recovery of patients on a 1 poor-5 excellent scale. Total score on scale 40 (poor recovery)-200 (excellent recovery)
Outcome measures
| Measure |
Deep Sedation
n=10 Participants
Deep sedation
Deep Sedation: IV administration of Propofol,initial rate 100ug/kg/min, titrated to maintain BIS 65-75,Fentanyl,Ketamine,1mcg/kg,0.5mg/kg,additional 10mg increments for analgesia/movement.
|
General Anesthesia
n=7 Participants
Administration of general anesthesia. Propofol given IV, succinylcholine and rocuronium given IV and Sevoflurane via the endotracheal tube.
General Anesthesia: Administer: Fentanyl:1mcg/kg prior to induction, additional doses to maintain blood pressure and heart rate within 20% of preoperative values, Propofol:2mg/kg,succinylcholine, 0.5mg/kg,to be followed with Rocuronium if necessary,bolus: 0.4mg/kg, Sevoflurane and oxygen to be titrated to maintain BIS value of 40-60.
|
|---|---|---|
|
Quality of Recovery - 40 Scores
|
183.4 Units on a scale
Standard Deviation 13.86
|
177.2 Units on a scale
Standard Deviation 16.84
|
Adverse Events
Deep Sedation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
General Anesthesia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place