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

September 12, 2013 updated by: Nisa Netinatsunton, Prince of Songkla University

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).

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Drug: Propofol
Propofol is the sedative drug used as an additional sedation to one of the study arm.
Other Names:
  • Diprivan
Drug: Midazolam
Midazolam is one of the two conventional sedative drugs included in both arms.
Other Names:
  • Benzodiazepine
Drug: Meperidine
Meperidine is one of the two conventional sedative drugs included in both arms.
Other Names:
  • Pethidine
ACTIVE_COMPARATOR: 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.
Drug: Midazolam
Midazolam is one of the two conventional sedative drugs included in both arms.
Other Names:
  • Benzodiazepine
Drug: Meperidine
Meperidine is one of the two conventional sedative drugs included in both arms.
Other Names:
  • Pethidine

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prince of Songkla University

Investigators

  • Principal Investigator: Nisa Netinatsunton, MD, NKC Institute of Gastroenterology and Hepatology, Prince of Songklanakarind University
  • Principal Investigator: Nisa Netinatsunton, MD, Prince of Songkla University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

September 27, 2012

First Submitted That Met QC Criteria

October 17, 2012

First Posted (ESTIMATE)

October 18, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 22, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1774906506805161

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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