Etomidate vs. Midazolam for Sedation During ERCP

Phase 4

Completed

• Conditions: Choledocholithiasis; Cholangiocarcinoma; Pancreatitis; Pancreatic Cancer
• Interventions: Drug: Etomidate; Drug: Midazolam; Drug: Meperidine

• Registration Number: NCT02027311
• Lead Sponsor: Cheju Halla General Hospital

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 Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-16
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Study First Submitted QC: 2014-01-03
• Study First Posted: 2014-01-06
• Results First Submitted: 2014-05-03
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-09
• Last Update Submitted: 2015-06-09
• Results First Posted: 2015-06-29
• Last Update Posted: 2015-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Etomidate	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.
Midazolam	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%.
Etomidate	Meperidine	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.
Midazolam	Meperidine	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%.

Primary Outcome Measures

Name	Time	Method
Number of Intervention	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.

Secondary Outcome Measures

Name	Time	Method
Event of Hypoxia	Every 5min in Preoperative, intraoperative phase and 15 min in Recovery phase	Hypoxia defined as peripheral blood oxygen saturation measured by pulse oxymeter \< 90%

Trial Locations

Locations (1)

1Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital; 🇰🇷 Jeju-si, Jeju Special Self-Governing Province, Korea, Republic of