Trial Outcomes & Findings for Etomidate vs. Midazolam for Sedation During ERCP (NCT NCT02027311)

NCT ID: NCT02027311

Last Updated: 2015-06-29

Results Overview

The frequency of intervention which was defined as any restraint of the patient's head, arms, or legs if they became agitated, or if patient movement was not controlled with verbal instruction from the endoscopist during the whole intraoperative phases.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 63 participants
• Primary outcome timeframe: Throughout the whole ERCP procedure
• Results posted on: 2015-06-29

Participant Flow

Eligibility was evaluated for all patients with a scheduled ERCP procedure in the Cheju Halla General Hospital during the study period from May 15 2013 to Aug 19 2013. Sample size estimated 26 of each groups for reject null hypothesis with probability (power) 0.8 and Type I error is 0.05.

68 patients were enrolled and 35 were assigned in the MDZ group and 33 were in the ETM group. In ETM group, 1 case was dropped due to hypotension and 2 were desaturation. And 1 cases was dropped due to tachycardia and 1 were desaturation in MDZ group.

Participant milestones

Measure	Etomidate This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted. Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted. Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders \> 80 years old were administered 25mg iv bolus.	Midazolam This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%. Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%. Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders \> 80 years old were administered 25mg iv bolus.
Overall Study STARTED	33	35
Overall Study COMPLETED	30	33
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	Etomidate This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted. Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted. Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders \> 80 years old were administered 25mg iv bolus.	Midazolam This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%. Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%. Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders \> 80 years old were administered 25mg iv bolus.
Overall Study Protocol Violation	3	2

Baseline Characteristics

Etomidate vs. Midazolam for Sedation During ERCP

Baseline characteristics by cohort

Measure	Etomidate n=30 Participants This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted. Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted. Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders \> 80 years old were administered 25mg iv bolus.	Midazolam n=33 Participants This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%. Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%. Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders \> 80 years old were administered 25mg iv bolus.	Total n=63 Participants Total of all reporting groups
Age, Continuous	70.3 years STANDARD_DEVIATION 15.7 • n=5 Participants	71.6 years STANDARD_DEVIATION 11.5 • n=7 Participants	70.9 years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Body Mass Index (kg/square of m.)	23.7 kg/square of m. STANDARD_DEVIATION 3.5 • n=5 Participants	22.6 kg/square of m. STANDARD_DEVIATION 4.31 • n=7 Participants	23.1 kg/square of m. STANDARD_DEVIATION 3.9 • n=5 Participants
Procedure Time (min)	27.6 min STANDARD_DEVIATION 14.9 • n=5 Participants	32.8 min STANDARD_DEVIATION 13.4 • n=7 Participants	30.4 min STANDARD_DEVIATION 14.2 • n=5 Participants

PRIMARY outcome

Timeframe: Throughout the whole ERCP procedure

The frequency of intervention which was defined as any restraint of the patient's head, arms, or legs if they became agitated, or if patient movement was not controlled with verbal instruction from the endoscopist during the whole intraoperative phases.

Outcome measures

Measure	Etomidate n=30 Participants This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted. Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted. Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders \> 80 years old were administered 25mg iv bolus.	Midazolam n=33 Participants This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%. Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%. Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders \> 80 years old were administered 25mg iv bolus.
Number of Intervention	1.9 Number of intervention Standard Deviation 3.1	7.5 Number of intervention Standard Deviation 6.8

SECONDARY outcome

Timeframe: Every 5min in Preoperative, intraoperative phase and 15 min in Recovery phase

Hypoxia defined as peripheral blood oxygen saturation measured by pulse oxymeter < 90%

Outcome measures

Measure	Etomidate n=33 Participants This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted. Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted. Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders \> 80 years old were administered 25mg iv bolus.	Midazolam n=30 Participants This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%. Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%. Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders \> 80 years old were administered 25mg iv bolus.
Event of Hypoxia	19 Hypoxia events	27 Hypoxia events

Adverse Events

Etomidate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Midazolam

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

Dr. Byung Hyo Cha, Director of ETOMI-1 study

Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital

Phone: +82-64-740-8050

Email: drhyo@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place