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

NCT ID: NCT01709422

Last Updated: 2013-10-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-11-30

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.

Conditions

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Disorders of Gallbladder, Biliary Tract and Pancrease

Keywords

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Propofol Midazolam Meperidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Propofol is the sedative drug used as an additional sedation to one of the study arm.

Midazolam

Intervention Type DRUG

Midazolam is one of the two conventional sedative drugs included in both arms.

Meperidine

Intervention Type DRUG

Meperidine is one of the two conventional sedative drugs included in both arms.

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.

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

Midazolam is one of the two conventional sedative drugs included in both arms.

Meperidine

Intervention Type DRUG

Meperidine is one of the two conventional sedative drugs included in both arms.

Interventions

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Propofol

Propofol is the sedative drug used as an additional sedation to one of the study arm.

Intervention Type DRUG

Midazolam

Midazolam is one of the two conventional sedative drugs included in both arms.

Intervention Type DRUG

Meperidine

Meperidine is one of the two conventional sedative drugs included in both arms.

Intervention Type DRUG

Other Intervention Names

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Diprivan Benzodiazepine Pethidine

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Nisa Netinatsunton

NKC Institute of Gastroenterology and Hepatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nisa Netinatsunton, MD

Role: PRINCIPAL_INVESTIGATOR

NKC Institute of Gastroenterology and Hepatology, Prince of Songklanakarind University

Nisa Netinatsunton, MD

Role: PRINCIPAL_INVESTIGATOR

Prince of Songkla University

Locations

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NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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1774906506805161

Identifier Type: -

Identifier Source: org_study_id