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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01746641

Enrollment

Registered

2012-12-11

Start date

2010-01-31

Completion date

2010-06-30

Last updated

2012-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Remifentanil, Propofol, Sedation, Endoscopy, Gastroenterology, Target controlled infusion effect site

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.

Interventions

DRUGRemifentanil

DRUGPropofol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
Level of consciousness	Every minute until the end of the procedure, expected average of 30 minutes	Ramsay scale.

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026