Safety and Efficacy of Fentanyl Versus Pethidine During Propofol-based Sedated Colonoscopy: Prospective Randomized Study

January 15, 2014 updated by: Yonsei University
During sedative colonoscopy, use of propofol have been increased world wide. The onset time of propofol is shorter than midazolam. However the most popular additive pain killer, pethidine show different pharmacodynamic feature. The pethidine has longer onset time than propofol (nearly 30 minutes) and require more time to recovery. For this reason, the use of fentanyl has been increased world widely. However, exact comparison of pethidine and fentanyl was not studied. Therefore, we designed this study to compare both drug to check satisfaction of this drug.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Division of Gastroenterology Department of Internal Medicine, Yonsei University College of Medicine
        • Contact:
          • Sung Pil Hong, MD
          • Phone Number: +82-2-2228-1988
          • Email: sphong@yuhs.ac

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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A patient who undergo screening colonoscopy with sedative agents
  • A patient over 20 years and under 65 years
  • A patient who agree to participate in this study

Exclusion Criteria:

  • A patient who is refered from outside hospital to remove previously noted colon polyp
  • The case who cannot be achieved cecal intubation because of poor bowel preparation
  • A patient who undergo sedative EGD just prior to colonoscopy
  • A patient who have allergy to propofol, pethidine, or fentanyl
  • A patient who have taken MAO inhibitor regularly
  • A patient who underwent colon resection surgery before colonoscopy
  • A patient who was diagnosed IBD before colonoscopy
  • Pregnant woman
  • A patient who cannot maintain sedation level because of significant cardiovascular disease, renal disease, pulmonary disease
  • A patient who do not agree to participate in this study
  • A patient who cannot understand this study because of foreigner or retarded mental status
  • A patient who have lower body weight, less than 37.5kg

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fentanyl arm
The subjects of this arm will consist of the patients who undergo colonoscopy with sedative agents, propofol and fentanyl.
Drug: fentanyl doses
fentanyl doses 50μg (37.5kg to 62.5kg), 75μg (62.5kg to 87.5kg), 100μg (>87.5kg), single use Propofol doses 1.0mg/kg IV bolus loading, 20mg, IV bolus, titration (up to MOAAS 5)
Active Comparator: Pethidine arm
The subjects of this arm will consist of the patients who undergo colonoscopy with sedative agents, propofol and pethidine.
Drug: pethidine dose
pethidine dose 50mg, IV bolus (25mg if < 50kg or >70 years or significant co-morbidity), Propofol doses 1.0mg/kg IV bolus loading, 20mg, IV bolus, titration (up to MOAAS 5)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction of subjects
Time Frame: 1 week later after colonoscopy
From previously reports, both pethidine and fentanyl are safe and effective agents for sedative colonoscopy. Therefore, we will check the subjects' satisfaction of procedure. If patients' satisfaction of procedure under one drug comparing to the others, we will select one drug as pain killer during colonoscopy.
1 week later after colonoscopy

Collaborators and Investigators

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

Sponsor

Yonsei 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.

General Publications

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

September 1, 2013

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

January 12, 2014

First Submitted That Met QC Criteria

January 15, 2014

First Posted (Estimate)

January 17, 2014

Study Record Updates

Last Update Posted (Estimate)

January 17, 2014

Last Update Submitted That Met QC Criteria

January 15, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2013-0351

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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