Clinical trial NCT01746641: Remifentanil Versus Propofol for TCI Sedation of Patients Undergoing Gastrointestinal Endoscopic Procedures
Official title: Remifentanil Versus Propofol With Target Controlled Infusion Effect Site for the Sedation of Patients During Gastrointestinal Endoscopic Procedures: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain
Keywords: Remifentanil
Propofol
Sedation
Endoscopy
Gastroenterology
Target controlled infusion effect site
Lead sponsor: Fundación Universitaria de Ciencias de la Salud
Sponsor class: OTHER
Collaborators: name: Hospital de San Jose
First posted: 2012-12-11
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Patient satisfaction
timeFrame: At the end of the procedure, expected average of 30 minutes
Secondary outcomes:
measure: Gastroenterologist satisfaction
timeFrame: At the end of the procedure, expected average of 30 minutes
measure: Adverse events
timeFrame: At the end of the procedure, expected average of 30 minutes
Other outcomes:
measure: Level of consciousness
timeFrame: Every minute until the end of the procedure, expected average of 30 minutes
Locations:
city: Bogota
country: Colombia
facility: Fundación Universitaria de Ciencias de la Salud
Study officials:
affiliation: Fundacion Universitaria de Ciencias de la Salud
name: Luis A Muñoz, MD
role: STUDY_DIRECTOR
affiliation: Fundacion Universitaria de Ciencias de la Salud
name: Luis E Reyes, MD
role: PRINCIPAL_INVESTIGATOR
References: