Efficacy and Safety Profiles of Sedation With Propofol Combined With Intravenous Midazolam and Meperidine Versus Intravenous Midazolam and Meperidine for Ambulatory Endoscopic Retrograde-cholangiopancreatography(ERCP).
Overview
- Phase
- Phase 4
- Intervention
- Propofol
- Conditions
- Disorders of Gallbladder, Biliary Tract and Pancrease
- Sponsor
- Prince of Songkla University
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Procedure Related Time
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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
Detailed 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.
Investigators
Nisa Netinatsunton
NKC Institute of Gastroenterology and Hepatology
Prince of Songkla University
Eligibility Criteria
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
Arms & Interventions
Propofol
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.
Intervention: Propofol
Propofol
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.
Intervention: Midazolam
Propofol
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.
Intervention: Meperidine
Conventional
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.
Intervention: Midazolam
Conventional
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.
Intervention: Meperidine
Outcomes
Primary Outcomes
Procedure Related Time
Time Frame: participants will be followed for the duration of procedure, an expected average of 2.0 hours ]
(1) induction time ( the time from sedation to scope intubation ), (2) procedure time ( the time from scope intubation to scope withdrawal ) and (3) recovery time ( the time from scope withdrawal to full recovery ).The induction time, procedural time and recovery time were recorded by the nurse in the endoscopy unit.
Secondary Outcomes
- Cardiovascular Adverse Events.(participants will be followed for the duration of procedure, an expected average of 2.0 hours)