Etomidate vs. Midazolam for Sedation During ERCP

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Brief Title

Etomidate vs. Midazolam for Sedation During ERCP

Official Title

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

Brief 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.
    

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 Phase

Phase 4

Study Type

Interventional


Primary Outcome

Number of Intervention

Secondary Outcome

 Event of Hypoxia

Condition

Choledocholithiasis

Intervention

Etomidate

Study Arms / Comparison Groups

 Etomidate
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

63

Start Date

April 2013

Completion Date

August 2013

Primary Completion Date

August 2013

Eligibility Criteria

        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.
      

Gender

All

Ages

20 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

BYUNG HYO CHA, Dr., , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT02027311

Organization ID

ETOMI-1


Responsible Party

Principal Investigator

Study Sponsor

Cheju Halla General Hospital


Study Sponsor

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


Verification Date

June 2015