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Etomidate vs. Midazolam for Sedation During ERCP

Information source: Cheju Halla General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Choledocholithiasis; Cholangiocarcinoma; Pancreatitis; Pancreatic Cancer

Intervention: Etomidate (Drug); Midazolam (Drug); Meperidine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Cheju Halla General Hospital

Official(s) and/or principal investigator(s):
BYUNG HYO CHA, Dr., Study Chair, Affiliation: Cheju Halla General Hospital, Doreongno 65, Jeju-si Jeju Special Self-Governing Province, Korea 690-766

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Number of Intervention

Secondary outcome: Event of Hypoxia

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.

Eligibility

Minimum age: 20 Years. Maximum age: 90 Years. Gender(s): Both.

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.

Locations and Contacts

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

Related publications:

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Starting date: April 2013
Last updated: June 9, 2015

Page last updated: August 23, 2015

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