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

This study has been terminated.
(Occurrence of severe respiratory depression in the remifentanil group.)
Sponsor:
Collaborator:
Hospital de San Jose
Information provided by (Responsible Party):
Fundación Universitaria de Ciencias de la Salud
ClinicalTrials.gov Identifier:
NCT01746641
First received: July 30, 2012
Last updated: December 8, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Pain
Drug: Remifentanil
Drug: Propofol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Remifentanil Versus Propofol With Target Controlled Infusion Effect Site for the Sedation of Patients During Gastrointestinal Endoscopic Procedures: Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Fundación Universitaria de Ciencias de la Salud:

Primary Outcome Measures:
  • Patient satisfaction [ Time Frame: At the end of the procedure, expected average of 30 minutes ] [ Designated as safety issue: No ]

    Measured with a analog scale from 1 to 4:

    1. Excellent.
    2. Good.
    3. Regular.
    4. No.


Secondary Outcome Measures:
  • Gastroenterologist satisfaction [ Time Frame: At the end of the procedure, expected average of 30 minutes ] [ Designated as safety issue: No ]

    Measured with a analog scale from 1 to 4:

    1. Excellent.
    2. Good.
    3. Regular.
    4. No.

  • Adverse events [ Time Frame: At the end of the procedure, expected average of 30 minutes ] [ Designated as safety issue: Yes ]
    Occurrence of cardiac arrythmias, mild respiratory depression, severe respiratory depression, bradycardia, hypotension, pain, nausea or vomiting, absence of amnesia.


Other Outcome Measures:
  • Level of consciousness [ Time Frame: Every minute until the end of the procedure, expected average of 30 minutes ] [ Designated as safety issue: No ]
    Ramsay scale.


Enrollment: 69
Study Start Date: January 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746641

Locations
Colombia
Fundación Universitaria de Ciencias de la Salud
Bogota, Colombia, 11001000
Sponsors and Collaborators
Fundación Universitaria de Ciencias de la Salud
Hospital de San Jose
Investigators
Study Director: Luis A Muñoz, MD Fundacion Universitaria de Ciencias de la Salud
Principal Investigator: Luis E Reyes, MD Fundacion Universitaria de Ciencias de la Salud
  More Information

No publications provided

Responsible Party: Fundación Universitaria de Ciencias de la Salud
ClinicalTrials.gov Identifier: NCT01746641     History of Changes
Other Study ID Numbers: Acta No. 197
Study First Received: July 30, 2012
Last Updated: December 8, 2012
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Colombia: Institutional Review Board

Keywords provided by Fundación Universitaria de Ciencias de la Salud:
Remifentanil
Propofol
Sedation
Endoscopy
Gastroenterology
Target controlled infusion effect site

Additional relevant MeSH terms:
Propofol
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014