Trial Outcomes & Findings for Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies (NCT NCT02038894)

NCT ID: NCT02038894

Last Updated: 2020-09-24

Results Overview

An important outcome in the anesthetic management of these patients is to maintain a balance between a safe technique with a minimal incidence of respiratory complications, and a technique that facilitates rapid turnover of the gastrointestinal suite. A chi-square test, or Fisher's exact test will measure differences among the three anesthetic groups. Different anesthetic techniques are currently in use at Cincinnati Children's Hospital Medical Center (CCHMC). Because there is a lack of evidence to delineate the best techniques, pediatric anesthesiologists select the technique based on clinical preference and experience.

Recruitment status

COMPLETED

Study phase

Target enrollment

179 participants

Primary outcome timeframe

Admission for surgery through recovery period, approximately 3 hours

Results posted on

2020-09-24

Participant Flow

Participant milestones

Participant milestones
Measure	Intubated With Sevoflurane (IS) Anesthetic technique during (EGD) Intubated with Sevoflurane (IS): Anesthesia will be maintained with sevoflurane 3% in oxygen at 2 L/min. The endoscopist will begin the procedure. The sevoflurane inspired concentration will be adjusted between 1 to 2 times the minimum alveolar concentration (MAC) by the attending anesthesiologist to maintain an appropriate level of anesthesia.	Intubated With Propofol (IP) Anesthetic technique during (EGD) Intubated with Propofol (IP): Anesthetic maintenance will be with 2 L/min flow of oxygen through the endotracheal tube and a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg and an increase in the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist if necessary to provide adequate anesthesia.	Native Airway - no Intubation Anesthetic technique during (EGD) Zofran - no intubation: A nasal cannula will be placed with oxygen administered at a rate of 3 L/min, and a bite block will be inserted. Zofran will be administered. Anesthesia will be maintained with a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg, and an increase of the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist. Propofol
Overall Study STARTED	60	58	61
Overall Study COMPLETED	60	58	61
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intubated With Sevoflurane (IS) n=60 Participants Anesthetic technique during (EGD) Intubated with Sevoflurane (IS): Anesthesia will be maintained with sevoflurane 3% in oxygen at 2 L/min. The endoscopist will begin the procedure. The sevoflurane inspired concentration will be adjusted between 1 to 2 times the minimum alveolar concentration (MAC) by the attending anesthesiologist to maintain an appropriate level of anesthesia.	Intubated With Propofol (IP) n=58 Participants Anesthetic technique during (EGD) Intubated with Propofol (IP): Anesthetic maintenance will be with 2 L/min flow of oxygen through the endotracheal tube and a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg and an increase in the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist if necessary to provide adequate anesthesia.	Native Airway - no Intubation n=61 Participants Anesthetic technique during (EGD) Zofran - no intubation: A nasal cannula will be placed with oxygen administered at a rate of 3 L/min, and a bite block will be inserted. Zofran will be administered. Anesthesia will be maintained with a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg, and an increase of the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist. Propofol	Total n=179 Participants Total of all reporting groups
Age, Continuous	8 years n=99 Participants	6 years n=107 Participants	7 years n=206 Participants	7 years n=7 Participants
Sex: Female, Male Female	27 Participants n=99 Participants	25 Participants n=107 Participants	26 Participants n=206 Participants	78 Participants n=7 Participants
Sex: Female, Male Male	33 Participants n=99 Participants	33 Participants n=107 Participants	35 Participants n=206 Participants	101 Participants n=7 Participants
Race/Ethnicity, Customized African American	4 Participants n=99 Participants	2 Participants n=107 Participants	2 Participants n=206 Participants	8 Participants n=7 Participants
Race/Ethnicity, Customized Asian	1 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants	3 Participants n=7 Participants
Race/Ethnicity, Customized Caucasian	55 Participants n=99 Participants	52 Participants n=107 Participants	51 Participants n=206 Participants	158 Participants n=7 Participants
Race/Ethnicity, Customized Other	0 Participants n=99 Participants	2 Participants n=107 Participants	6 Participants n=206 Participants	8 Participants n=7 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=7 Participants
Region of Enrollment United States	60 Participants n=99 Participants	58 Participants n=107 Participants	61 Participants n=206 Participants	179 Participants n=7 Participants
Weight	25 kg n=99 Participants	22.7 kg n=107 Participants	22.5 kg n=206 Participants	24.3 kg n=7 Participants
BMI	16 kg/m^2 n=99 Participants	16.1 kg/m^2 n=107 Participants	16.6 kg/m^2 n=206 Participants	16.4 kg/m^2 n=7 Participants
BMI Percent	46 percentile n=99 Participants	57.1 percentile n=107 Participants	67 percentile n=206 Participants	56.8 percentile n=7 Participants
American Society of Anesthesiologists - ASA Physical Status (Patient's health condition) ASA 1 (Normal healthy subject)	13 Participants n=99 Participants	15 Participants n=107 Participants	10 Participants n=206 Participants	38 Participants n=7 Participants
American Society of Anesthesiologists - ASA Physical Status (Patient's health condition) ASA 2 (Mild systemic disease)	47 Participants n=99 Participants	43 Participants n=107 Participants	50 Participants n=206 Participants	140 Participants n=7 Participants
American Society of Anesthesiologists - ASA Physical Status (Patient's health condition) Missing or Unknown	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	1 Participants n=7 Participants
Diagnosis Abdominal Pain	15 Participants n=99 Participants	20 Participants n=107 Participants	15 Participants n=206 Participants	50 Participants n=7 Participants
Diagnosis Chronic Diarrhea	3 Participants n=99 Participants	3 Participants n=107 Participants	1 Participants n=206 Participants	7 Participants n=7 Participants
Diagnosis Diarrhea	1 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	2 Participants n=7 Participants
Diagnosis Dysphagia	4 Participants n=99 Participants	3 Participants n=107 Participants	0 Participants n=206 Participants	7 Participants n=7 Participants
Diagnosis Eosinophilic esophagitis	18 Participants n=99 Participants	10 Participants n=107 Participants	24 Participants n=206 Participants	52 Participants n=7 Participants
Diagnosis Failure to Thrive	5 Participants n=99 Participants	3 Participants n=107 Participants	5 Participants n=206 Participants	13 Participants n=7 Participants
Diagnosis Feeding Difficulties	2 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	3 Participants n=7 Participants
Diagnosis GERD	6 Participants n=99 Participants	5 Participants n=107 Participants	8 Participants n=206 Participants	19 Participants n=7 Participants
Diagnosis Nausea/Vomit	4 Participants n=99 Participants	9 Participants n=107 Participants	7 Participants n=206 Participants	20 Participants n=7 Participants
Diagnosis Rumination Syndrome	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=7 Participants

PRIMARY outcome

Timeframe: Admission for surgery through recovery period, approximately 3 hours

Outcome measures

Outcome measures
Measure	Intubated With Sevoflurane (IS) n=60 Participants Anesthetic technique during (EGD) Intubated with Sevoflurane (IS): Anesthesia will be maintained with sevoflurane 3% in oxygen at 2 L/min. The endoscopist will begin the procedure. The sevoflurane inspired concentration will be adjusted between 1 to 2 times the minimum alveolar concentration (MAC) by the attending anesthesiologist to maintain an appropriate level of anesthesia.	Intubated With Propofol (IP) n=58 Participants Anesthetic technique during (EGD) Intubated with Propofol (IP): Anesthetic maintenance will be with 2 L/min flow of oxygen through the endotracheal tube and a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg and an increase in the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist if necessary to provide adequate anesthesia.	Native Airway - no Intubation n=61 Participants Anesthetic technique during (EGD) Zofran - no intubation: A nasal cannula will be placed with oxygen administered at a rate of 3 L/min, and a bite block will be inserted. Zofran will be administered. Anesthesia will be maintained with a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg, and an increase of the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist. Propofol	IS and IP n=118 Participants Grouping the intubated with sevoflurane group (IS) with the intubated with propofol group (IP) since the airway management is the same for both groups (endotracheal intubation) Table 2	IP and NA n=119 Participants Grouping the intubated propofol group (IP) with the native airway group (NA) since they received the same medication during the procedure (propofol). Table 2
Number of Participants With Respiratory Complications SPO2 < 95%	0 Participants	0 Participants	15 Participants	0 Participants	15 Participants
Number of Participants With Respiratory Complications SPO2 < 85%	0 Participants	0 Participants	9 Participants	0 Participants	8 Participants
Number of Participants With Respiratory Complications Inadequate Anesthesia	1 Participants	4 Participants	9 Participants	5 Participants	13 Participants
Number of Participants With Respiratory Complications Apnea	0 Participants	1 Participants	5 Participants	1 Participants	5 Participants
Number of Participants With Respiratory Complications All Respiratory Events	2 Participants	5 Participants	28 Participants	7 Participants	32 Participants

SECONDARY outcome

Timeframe: Admission for surgery through recovery period, approximately 3 hours

Time measurements are used to evaluate the efficiency of the different techniques. We will compare the times spent in the operating room and the postoperative unit for each technique.

Outcome measures

Outcome measures
Measure	Intubated With Sevoflurane (IS) n=60 Participants Anesthetic technique during (EGD) Intubated with Sevoflurane (IS): Anesthesia will be maintained with sevoflurane 3% in oxygen at 2 L/min. The endoscopist will begin the procedure. The sevoflurane inspired concentration will be adjusted between 1 to 2 times the minimum alveolar concentration (MAC) by the attending anesthesiologist to maintain an appropriate level of anesthesia.	Intubated With Propofol (IP) n=58 Participants Anesthetic technique during (EGD) Intubated with Propofol (IP): Anesthetic maintenance will be with 2 L/min flow of oxygen through the endotracheal tube and a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg and an increase in the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist if necessary to provide adequate anesthesia.	Native Airway - no Intubation n=61 Participants Anesthetic technique during (EGD) Zofran - no intubation: A nasal cannula will be placed with oxygen administered at a rate of 3 L/min, and a bite block will be inserted. Zofran will be administered. Anesthesia will be maintained with a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg, and an increase of the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist. Propofol	IS and IP n=118 Participants Grouping the intubated with sevoflurane group (IS) with the intubated with propofol group (IP) since the airway management is the same for both groups (endotracheal intubation) Table 2	IP and NA n=119 Participants Grouping the intubated propofol group (IP) with the native airway group (NA) since they received the same medication during the procedure (propofol). Table 2
Peri-operative Times Between Three Different Anesthetic Techniques OR Time	24.03 Minutes Standard Deviation 6.00	24.19 Minutes Standard Deviation 7.54	23.05 Minutes Standard Deviation 7.97	24.11 Minutes Standard Deviation 6.77	23.61 Minutes Standard Deviation 7.75
Peri-operative Times Between Three Different Anesthetic Techniques Anesthesia Preparation Time	10.86 Minutes Standard Deviation 2.53	10.70 Minutes Standard Deviation 2.70	10.35 Minutes Standard Deviation 3.35	10.78 Minutes Standard Deviation 2.60	10.53 Minutes Standard Deviation 3.03
Peri-operative Times Between Three Different Anesthetic Techniques Procedural Time	9.07 Minutes Standard Deviation 4.78	9.23 Minutes Standard Deviation 5.46	8.33 Minutes Standard Deviation 4.18	9.15 Minutes Standard Deviation 5.11	8.78 Minutes Standard Deviation 4.86
Peri-operative Times Between Three Different Anesthetic Techniques PACU efficiency time	49.50 Minutes Standard Deviation 14.31	53.49 Minutes Standard Deviation 12.68	54.42 Minutes Standard Deviation 22.59	51.48 Minutes Standard Deviation 13.61	53.96 Minutes Standard Deviation 18.24
Peri-operative Times Between Three Different Anesthetic Techniques Total Perioperative Time	75.34 Minutes Standard Deviation 15.40	79.61 Minutes Standard Deviation 14.45	79.37 Minutes Standard Deviation 25.17	77.46 Minutes Standard Deviation 15.03	79.49 Minutes Standard Deviation 20.43

Adverse Events

Intubated With Sevoflurane (IS)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Intubated With Propofol (IP)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Native Airway - no Intubation

Serious events: 14 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intubated With Sevoflurane (IS) n=60 participants at risk Anesthetic technique during (EGD) Intubated with Sevoflurane (IS): Anesthesia will be maintained with sevoflurane 3% in oxygen at 2 L/min. The endoscopist will begin the procedure. The sevoflurane inspired concentration will be adjusted between 1 to 2 times the minimum alveolar concentration (MAC) by the attending anesthesiologist to maintain an appropriate level of anesthesia.	Intubated With Propofol (IP) n=58 participants at risk Anesthetic technique during (EGD) Intubated with Propofol (IP): Anesthetic maintenance will be with 2 L/min flow of oxygen through the endotracheal tube and a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg and an increase in the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist if necessary to provide adequate anesthesia.	Native Airway - no Intubation n=61 participants at risk Anesthetic technique during (EGD) Zofran - no intubation: A nasal cannula will be placed with oxygen administered at a rate of 3 L/min, and a bite block will be inserted. Zofran will be administered. Anesthesia will be maintained with a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg, and an increase of the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist. Propofol
Respiratory, thoracic and mediastinal disorders Severe desaturation: SpO2 < 85%	0.00% 0/60	0.00% 0/58	14.8% 9/61 • Number of events 9
Respiratory, thoracic and mediastinal disorders Apnea	0.00% 0/60	1.7% 1/58 • Number of events 1	8.2% 5/61 • Number of events 5

Other adverse events

Other adverse events
Measure	Intubated With Sevoflurane (IS) n=60 participants at risk Anesthetic technique during (EGD) Intubated with Sevoflurane (IS): Anesthesia will be maintained with sevoflurane 3% in oxygen at 2 L/min. The endoscopist will begin the procedure. The sevoflurane inspired concentration will be adjusted between 1 to 2 times the minimum alveolar concentration (MAC) by the attending anesthesiologist to maintain an appropriate level of anesthesia.	Intubated With Propofol (IP) n=58 participants at risk Anesthetic technique during (EGD) Intubated with Propofol (IP): Anesthetic maintenance will be with 2 L/min flow of oxygen through the endotracheal tube and a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg and an increase in the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist if necessary to provide adequate anesthesia.	Native Airway - no Intubation n=61 participants at risk Anesthetic technique during (EGD) Zofran - no intubation: A nasal cannula will be placed with oxygen administered at a rate of 3 L/min, and a bite block will be inserted. Zofran will be administered. Anesthesia will be maintained with a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg, and an increase of the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist. Propofol
Respiratory, thoracic and mediastinal disorders Minor desaturation < 95%	0.00% 0/60	0.00% 0/58	24.6% 15/61 • Number of events 15
Surgical and medical procedures Inadequate anesthesia	1.7% 1/60 • Number of events 1	6.9% 4/58 • Number of events 4	14.8% 9/61 • Number of events 9

Additional Information

Dr. Mario Patino

Cincinnati Children's Hospital Medical Center

Phone: 5132538190

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place