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

Phase 4TerminatedNCT01746641

Fundación Universitaria de Ciencias de la Salud69 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Pain

Interventions

RemifentanilDRUG

PropofolDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fundación Universitaria de Ciencias de la Salud

Bogotá, Bogota D.C., Colombia

Outcomes

Primary Outcomes

Patient satisfaction

Measured with a analog scale from 1 to 4: 1. Excellent. 2. Good. 3. Regular. 4. No.

Time frame: At the end of the procedure, expected average of 30 minutes

Secondary Outcomes

Gastroenterologist satisfaction

Measured with a analog scale from 1 to 4: 1. Excellent. 2. Good. 3. Regular. 4. No.

Time frame: 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.

Time frame: At the end of the procedure, expected average of 30 minutes

Data from ClinicalTrials.gov

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