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

Phase 4

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Conventional	Midazolam	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.
Propofol	Midazolam	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.
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.
Propofol	Meperidine	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.
Conventional	Meperidine	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.

Primary Outcome Measures

Name	Time	Method
Procedure Related Time	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 Outcome Measures

Name	Time	Method
Cardiovascular Adverse Events.	participants will be followed for the duration of procedure, an expected average of 2.0 hours	(1) desaturation(oxygen saturation \< 90 % at least 10 second ) (2) hypotension ( systolic blood pressure \< 90 mmHg or dropped more than 25 % of baseline ) (3)bradycardia (heart rate \< 50 beats/min) and (4) apnea ( cessation of respiratory activity for over 10 seconds ). When patients developed oxygen saturation \< 90 %, then nasal oxygen was administered, If patients not able to recover from oxygen therapy and tactile stimulations thus the procedure was terminated. The procedure was terminated if patients developed serious adverse event as heart rate below 5 beats/min and or apnea.