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

Information source: Prince of Songkla University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Disorders of Gallbladder, Biliary Tract and Pancrease

Intervention: Propofol (Drug); Midazolam (Drug); Meperidine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Prince of Songkla University

Official(s) and/or principal investigator(s):
Nisa Netinatsunton, MD, Principal Investigator, Affiliation: NKC Institute of Gastroenterology and Hepatology, Prince of Songklanakarind University
Nisa Netinatsunton, MD, Principal Investigator, Affiliation: Prince of Songkla University

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

Clinical Details

Official title: 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).

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome: Procedure Related Time

Secondary outcome: Cardiovascular Adverse Events.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University, Hatyai, Songkhla 90110, Thailand
Additional Information

Prince of Songkhla University

Starting date: June 2010
Last updated: September 12, 2013

Page last updated: August 23, 2015

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