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Etomidate vs. Midazolam for Sedation During ERCP

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ClinicalTrials.gov Identifier: NCT02027311
Recruitment Status : Completed
First Posted : January 6, 2014
Results First Posted : June 29, 2015
Last Update Posted : June 29, 2015
Sponsor:
Information provided by (Responsible Party):
Byung Hyo Cha, MD, Cheju Halla General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Choledocholithiasis
Cholangiocarcinoma
Pancreatitis
Pancreatic Cancer
Interventions Drug: Etomidate
Drug: Midazolam
Drug: Meperidine
Enrollment 63
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Etomidate Midazolam
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 33 35
Completed 30 [1] 33 [2]
Not Completed 3 2
Reason Not Completed
Protocol Violation             3             2
[1]
1 case was dropped due to hypotension and 2 were desaturation.
[2]
1 cases was dropped due to tachycardia and 1 were desaturation.
Arm/Group Title Etomidate Midazolam Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 30 33 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 33 participants 63 participants
70.3  (15.7) 71.6  (11.5) 70.9  (13.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 33 participants 63 participants
Female
16
  53.3%
19
  57.6%
35
  55.6%
Male
14
  46.7%
14
  42.4%
28
  44.4%
Body Mass Index (kg/square of m.)  
Mean (Standard Deviation)
Unit of measure:  Kg/square of m.
Number Analyzed 30 participants 33 participants 63 participants
23.7  (3.5) 22.6  (4.31) 23.1  (3.9)
Procedure Time (min)  
Mean (Standard Deviation)
Unit of measure:  Min
Number Analyzed 30 participants 33 participants 63 participants
27.6  (14.9) 32.8  (13.4) 30.4  (14.2)
1.Primary Outcome
Title Number of Intervention
Hide Description 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.
Time Frame Throughout the whole ERCP procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etomidate Midazolam
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 30 33
Mean (Standard Deviation)
Unit of Measure: Number of intervention
1.9  (3.1) 7.5  (6.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etomidate, Midazolam
Comments If the true difference in the experimental and control means is 4, total 26 experimental subjects and 26 control subjects was required to reject the null hypothesis that the means of the primary outcome values of experimental and control groups are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments For two-sided tests, p < 0.05 was considered statistically significant.
Method Regression, Logistic
Comments Logistic regression model used to identify the factors related to the presence of intervention (frequency of intervention = 0, vs. ≥ 1).
2.Secondary Outcome
Title Event of Hypoxia
Hide Description Hypoxia defined as peripheral blood oxygen saturation measured by pulse oxymeter < 90%
Time Frame Every 5min in Preoperative, intraoperative phase and 15 min in Recovery phase
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Midazolam Etomidate
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 33 30
Measure Type: Number
Unit of Measure: Hypoxia events
19 27
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Midazolam, Etomidate
Comments All the continuous variables were compared using the Mann-Whitney U test and dichotomous categorical variables was used and the Pearson chi-square with Fisher exact test. We used the linear mixed model to compare the differences of paired data, such as mean values of RR, SpO2, MAP, HR, and RSS at different time points of the two different sedation groups. For two-sided tests, p < 0.05 was considered statistically significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Logistic regression model were used in univariate and corrected multivariate analyses to identify the factors related to the primary outcome variables, such as, presence of intervention (frequency of intervention = 0, vs. ≥ 1).
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 11.09
Confidence Interval (2-Sided) 95%
2.41 to 50.94
Estimation Comments [Not Specified]
Time Frame BP, RR, HR, and SpO2 were monitored at 5-minute intervals after the baseline measurements until the termination of the ERCP. The baseline measurements were obtained at least 15 minutes before any medication was administered to patients.
Adverse Event Reporting Description Additional probable side events, such as, paradoxic reaction in MDZ group, and myoclonus in ETM group were counted during the whole 3 phases of procedure.
 
Arm/Group Title Etomidate Midazolam
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Etomidate Midazolam
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Etomidate Midazolam
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/33 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Etomidate Midazolam
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/33 (0.00%) 
  1. To standardize proper sedation level we used Ramsay Sedation Scale but this scale could be calculated subjectively.
  2. Double blindness was not applied strictly because of quite different pharmacodynamics of two experimental drugs.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Byung Hyo Cha, Director of ETOMI-1 study
Organization: Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital
Phone: +82-64-740-8050
EMail: drhyo@hotmail.com
Publications:
Layout table for additonal information
Responsible Party: Byung Hyo Cha, MD, Cheju Halla General Hospital
ClinicalTrials.gov Identifier: NCT02027311     History of Changes
Other Study ID Numbers: ETOMI-1
First Submitted: April 16, 2013
First Posted: January 6, 2014
Results First Submitted: May 3, 2014
Results First Posted: June 29, 2015
Last Update Posted: June 29, 2015