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

NCT01709422 | Completed Phase 4 Results DMC

• 1 other identifier: 1774906506805161
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Disorders of Gallbladder, Biliary Tract and Pancrease

Keywords

Propofol; Midazolam; Meperidine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cardiovascular Adverse Events.

  participants will be followed for the duration of procedure, an expected average of 2.0 hours

Study Arms (2)

Propofol

ACTIVE COMPARATOR

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; Drug: Midazolam; Drug: Meperidine

Conventional

ACTIVE COMPARATOR

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; Drug: Meperidine

Interventions

Propofol DRUG

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

Also known as: Diprivan

Propofol

Midazolam DRUG

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

Also known as: Benzodiazepine

Conventional; Propofol

Meperidine DRUG

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

Also known as: Pethidine

Conventional; Propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All outpatients aged more than 18 years who were schedule for ERCP -

You may not qualify if:

• 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

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Interventions

Propofol; Midazolam; Benzodiazepines; Meperidine

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Isonipecotic Acids; Acids, Heterocyclic; Piperidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Nisa Netinatsunton
• Organization: Prince of Songkhla University

nisasan@yahoo.com

6674451965

Study Officials

• Nisa Netinatsunton, MD

  NKC Institute of Gastroenterology and Hepatology, Prince of Songklanakarind University

  PRINCIPAL INVESTIGATOR

• Nisa Netinatsunton, MD

  Prince of Songkla University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NKC Institute of Gastroenterology and Hepatology

Study Record Dates

• First Submitted: September 27, 2012
• First Posted: October 18, 2012
• Study Start: June 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: October 22, 2013
• Results First Posted: August 27, 2013

Record last verified: 2013-09

Locations

TH (1)