Etomidate vs. Midazolam for Sedation During ERCP

June 9, 2015 updated by: Byung Hyo Cha, MD, Cheju Halla General Hospital

Etomidate With Meperidine vs Midazolam With Meperidine for Sedation During Endodscopic Retrograde Cholangiopancreatogram (ERCP)

Recently up-coming drug, etomidate which is a modulator of GABA(gamma-Aminobutyric acid)-A receptor has been known that it maintains the appropriate sedative levels and affects little effects on respiratory system.

The investigators are now trying to investigate that etomidate with meperidine combination regimen is superior to the midazolam with meperidine more effective and less harm on sedation during the ERCP procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

ERCP (Endoscopic retrograde cholangiopancreatogram) is an uncomfortable and time-consuming procedure compared to other endoscopic procedures. Most ERCP procedure had been performed in sedation using tranquilizers and pain-killers.

Until recently, midazolam and opioid combination regimen recognized as a standard therapy is widely used, but the sedative effect is insufficient and intermittent paradoxical reaction has been questioned. Another drug, such as propofol, has been known that the sedative effect is superior one of the midazolam but disappointed due to narrow therapeutic range of respiratory distress and absence of antagonist. Meanwhile, recently up-coming drug, etomidate which is a modulator of GABA-A receptor has been known that it maintains the appropriate sedative levels and affects little effects on respiratory system.

For these advantages, this short acting sedative drug has been widely used in the emergency room during minor operation and in the operation room for induction. However, research on the efficacy during ERCP was not yet published.

In this regards, the purpose of the investigators study is to prove the efficacy of etomidate for sedation and to establish new evidence based sedation guidelines during ERCP procedure.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jeju Special Self-Governing Province
      • Jeju-si, Jeju Special Self-Governing Province, Korea, Republic of, 690-766
        • 1Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients who are scheduled diagnositic or therapeutic ERCP.
  • Age : more than 20 and less than 90 years old
  • ASA(American Society of Anesthesiologists) classificiation : I, II, III

Exclusion Criteria:Patients following

  • Refuse to be enrolled
  • ASA American Society of Anesthesiologists)classification IV, V
  • Breast feeder
  • The mentally ill
  • Drug abuser
  • Hypersensitivity to sedative or opioids
  • Alcohol intoxication or dependency
  • Body mass index (BMI) 36kg/m2 or more

  • Unstable vital sign

    1. tachypnea, respiration rate more than 25/min or less than 10/min
    2. Oxygen saturation : 90% or less
    3. Systolic blood pressure : less than 90 mmHg or more than 180 mmHg
    4. Diastolic blood pressure : less than 50 mmHg or more than 100 mmHg
    5. Heart rate : more than 120 beat/min or less than 50 beat/min.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Other Names:
  • Etomidate lipro IV
Drug: Meperidine
Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus.
Other Names:
  • Pethidine
Experimental: 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%.
Drug: Meperidine
Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus.
Other Names:
  • Pethidine
Drug: 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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Intervention
Time Frame: 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.
Throughout the whole ERCP procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event of Hypoxia
Time Frame: Every 5min in Preoperative, intraoperative phase and 15 min in Recovery phase
Hypoxia defined as peripheral blood oxygen saturation measured by pulse oxymeter < 90%
Every 5min in Preoperative, intraoperative phase and 15 min in Recovery phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cheju Halla General Hospital

Investigators

  • Study Chair: BYUNG HYO CHA, Dr., Cheju Halla General Hospital, Doreongno 65, Jeju-si Jeju Special Self-Governing Province, Korea 690-766

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

April 16, 2013

First Submitted That Met QC Criteria

January 3, 2014

First Posted (Estimate)

January 6, 2014

Study Record Updates

Last Update Posted (Estimate)

June 29, 2015

Last Update Submitted That Met QC Criteria

June 9, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETOMI-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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