Efficacy and Safety Profiles of Combination Sedation Propofol With Midazolam and Meperidine. (ERCP)

Prince of Songkla University

Status and phase: Completed; Phase 4

Conditions: Disorders of Gallbladder, Biliary Tract and Pancrease

Treatments: Drug: Meperidine; Drug: Propofol; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT01709422

1774906506805161

Details and patient eligibility

About

The purpose of this study is to compare efficacy and safety of combination of propofol and midazolam with meperidine versus midazolam and meperidine for ambulatory ERCP

Full description

ERCP is commonly done under sedation with midazolam and meperidine, however some studies showed varying outcomes of this conventional sedation for maintained sedation. Propofol is increasing used for sedation in gastrointestinal procedure owing to its rapid recovery profiles but the complications associated with propofol are not negligible.The investigators prospectively compare the efficacy, induction time, recovery time, patient satisfaction and side effect between propofol based and conventional sedations in patients undergoing ERCP.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

. All outpatients aged more than 18 years who were schedule for ERCP -

Exclusion criteria

• pregnant woman
• emergency situation ( i.e. concomitant upper gastrointestinal bleeding, acute cholangitis )
• American Society of Anesthesiologist ( ASA )Class IV or V
• respiratory disease,
• sleep apnea
• allergy to egg or soybean
• drug abuse( benzodiazepine, opioid agonist )
• previous history of failure sedation

Trial design

140 participants in 2 patient groups

Propofol

Active Comparator group

Description:

both midazolam (1mg if aged \<= 70 years or 0.5mg in age \>70 years) and meperidine 20 mg were given intravenously at the initiation of sedation, Thereafter, an initial bolus of propofol 20 mg intravenously. Sedation was maintained with repeated dose of 5 to 10 mg propofol.

Treatment:

Drug: Midazolam

Drug: Propofol

Drug: Meperidine

Conventional

Active Comparator group

Description:

both midazolam 2 to 5 mg and meperidine 25 to 50 mg were given intravenously at the initiation of sedation. Sedation was maintained with repeated doses of 0.5 to 1.0 mg midazolam and 5 to 10 mg meperidine.

Treatment:

Drug: Midazolam

Drug: Meperidine