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

Phase 4

Terminated

• Conditions: Pain
• Interventions: Drug: Propofol; Drug: Remifentanil

• Registration Number: NCT01746641
• Lead Sponsor: Fundación Universitaria de Ciencias de la Salud

Brief Summary

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

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 Timeline

• Study Start: 2010-01
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Study First Submitted: 2012-07-30
• Status Verified: 2012-12
• Study First Submitted QC: 2012-12-08
• Last Update Submitted: 2012-12-08
• Study First Posted: 2012-12-11
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 69

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	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.
Remifentanil	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.

Primary Outcome Measures

Name	Time	Method
Patient satisfaction	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.

Secondary Outcome Measures

Name	Time	Method
Gastroenterologist satisfaction	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.
Adverse events	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.

Trial Locations

Locations (1)

Fundación Universitaria de Ciencias de la Salud; 🇨🇴 Bogota, Colombia