Remifentanil Versus Propofol for TCI Sedation of Patients Undergoing Gastrointestinal Endoscopic Procedures

December 8, 2012 updated by: Fundación Universitaria de Ciencias de la Salud

Remifentanil Versus Propofol With Target Controlled Infusion Effect Site for the Sedation of Patients During Gastrointestinal Endoscopic Procedures: Randomized Controlled Trial

The purpose of this study was to compare remifentanil and propofol for sedation of patients during endoscopic gastrointestinal procedures.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The administration of sedation with target controlled infusion (TCI) systems could offer a safe alternative for the management of discomfort of patients undergoing endoscopic gastrointestinal procedures. However, what medication from those available for TCI would be the most appropriate is not known.

Sixty-nine patients requiring a gastrointestinal endoscopic procedure were randomly assigned to receive a TCI effect site (e) of remifentanil (n=30) or propofol (n=39). The primary outcome was patient satisfaction. Secondary outcomes included gastroenterologist satisfaction, the proportion of adverse events between the two groups were compared (occurrence of cardiac arrhythmias, mild respiratory depression, major respiratory depression, bradycardia, hypotension, pain, nausea or vomiting, and lack of amnesia), and the level of consciousness.

Study Type

Interventional

Enrollment (Actual)

69

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

  • Colombia
      • Bogota, Colombia, 11001000
        • Fundación Universitaria de Ciencias de la Salud

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient undergoing elective higher, lower or mixed gastrointestinal endoscopy at Hospital de San Jose, Bogota, between January and December 2010.
  • Be between 18 and 70 years old.
  • American Society of Anesthesiology Physical Status classification between 1 and 3.
  • Provide written informed consent.

Exclusion Criteria:

  • Patients with difficult airway indicators.
  • Pregnant women.
  • Patients with chronic pain.
  • Chronic opioid or benzodiazepine users (>3 months).
  • Allergy history to remifentanil or propofol or eggs.
  • Psychoactive drug users.
  • Smokers (> 5 cigarettes per day in the previous 3 months).
  • Body mass index > 30.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Remifentanil

Remifentanil target controlled infusion effect site with Minto's pharmacokinetic model.

Start dose: 1 ng/mL. Titration: 0.5 ng/mL according to clinical criteria.
Drug: Remifentanil
Active Comparator: Propofol

Propofol target controlled infusion effect site with Marsh's pharmacokinetic model.

Start dose: 1 mcg/mL. Titration: 0.5 mcg/mL according to clinical criteria.
Drug: Propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: At the end of the procedure, expected average of 30 minutes

Measured with a analog scale from 1 to 4:

  1. Excellent.
  2. Good.
  3. Regular.
  4. No.
At the end of the procedure, expected average of 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastroenterologist satisfaction
Time Frame: At the end of the procedure, expected average of 30 minutes

Measured with a analog scale from 1 to 4:

  1. Excellent.
  2. Good.
  3. Regular.
  4. No.
At the end of the procedure, expected average of 30 minutes
Adverse events
Time Frame: At the end of the procedure, expected average of 30 minutes
Occurrence of cardiac arrythmias, mild respiratory depression, severe respiratory depression, bradycardia, hypotension, pain, nausea or vomiting, absence of amnesia.
At the end of the procedure, expected average of 30 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of consciousness
Time Frame: Every minute until the end of the procedure, expected average of 30 minutes
Ramsay scale.
Every minute until the end of the procedure, expected average of 30 minutes

Collaborators and Investigators

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

Sponsor

Fundación Universitaria de Ciencias de la Salud

Collaborators

Hospital de San Jose

Investigators

  • Principal Investigator: Luis E Reyes, MD, Fundación Universitaria de Ciencias de la Salud
  • Study Director: Luis A Muñoz, MD, Fundación Universitaria de Ciencias de la Salud

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

January 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

July 30, 2012

First Submitted That Met QC Criteria

December 8, 2012

First Posted (Estimate)

December 11, 2012

Study Record Updates

Last Update Posted (Estimate)

December 11, 2012

Last Update Submitted That Met QC Criteria

December 8, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Acta No. 197

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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