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

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: Pain
• Intervention / Treatment: Drug: Propofol; Drug: Remifentanil

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Measured with a analog scale from 1 to 4: Excellent.; Good.; Regular.; No.	At the end of the procedure, expected average of 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastroenterologist satisfaction	Measured with a analog scale from 1 to 4: Excellent.; Good.; Regular.; No.	At the end of the procedure, expected average of 30 minutes
Adverse events	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	Ramsay scale.	Every minute until the end of the procedure, expected average of 30 minutes

Collaborators and Investigators

• 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

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: Remifentanil; Endoscopy; Sedation; Propofol; Gastroenterology; Target controlled infusion effect site
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Remifentanil; Propofol
• Other Study ID Numbers: Acta No. 197