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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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).

Conditions
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Disorders of Gallbladder, Biliary Tract and Pancrease

Intervention / Treatment
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* Drug: Propofol
* Drug: Midazolam
* Drug: Meperidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br>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. | Drug: Propofol<br>* Propofol is the sedative drug used as an additional sedation to one of the study arm.<br>* Other names: Diprivan;Drug: Midazolam<br>* Midazolam is one of the two conventional sedative drugs included in both arms.<br>* Other names: Benzodiazepine;Drug: Meperidine<br>* Meperidine is one of the two conventional sedative drugs included in both arms.<br>* Other names: Pethidine;|
| Active Comparator: Conventional<br>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. | Drug: Midazolam<br>* Midazolam is one of the two conventional sedative drugs included in both arms.<br>* Other names: Benzodiazepine;Drug: Meperidine<br>* Meperidine is one of the two conventional sedative drugs included in both arms.<br>* Other names: Pethidine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Related Time | (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. | participants will be followed for the duration of procedure, an expected average of 2.0 hours ] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Adverse Events. | (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. | participants will be followed for the duration of procedure, an expected average of 2.0 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Propofol, Midazolam, Meperidine