Etomidate vs. Midazolam for Sedation During ERCP

Last updated: June 9, 2015
Sponsor: Cheju Halla General Hospital
Overall Status: Completed

Phase

4

Condition

Pancreatic Cancer

Digestive System Neoplasms

Pancreatic Disorders

Treatment

N/A

Clinical Study ID

NCT02027311
ETOMI-1
  • Ages 20-90
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 63
Study Start date:
April 01, 2013
Estimated Completion Date:
August 31, 2013

Study 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.

Connect with a study center

  • 1Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital

    Jeju-si, Jeju Special Self-Governing Province 690-766
    Korea, Republic of

    Site Not Available

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