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

Sponsor

Fundación Universitaria de Ciencias de la Salud (Other)

Overall Status

Terminated

CT.gov ID

NCT01746641

Collaborator

Hospital de San Jose (Other)

Enrollment

Location

Arms

Duration (Months)

13.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Remifentanil Drug: Propofol	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

69 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Remifentanil Versus Propofol With Target Controlled Infusion Effect Site for the Sedation of Patients During Gastrointestinal Endoscopic Procedures: Randomized Controlled Trial

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Gastroenterologist satisfaction [At the end of the procedure, expected average of 30 minutes]
Measured with a analog scale from 1 to 4: Excellent. Good. Regular. 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 Outcome Measures

Level of consciousness [Every minute until the end of the procedure, expected average of 30 minutes]
Ramsay scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fundación Universitaria de Ciencias de la Salud	Bogota		Colombia	11001000

Sponsors and Collaborators

Fundación Universitaria de Ciencias de la Salud
Hospital de San Jose

Investigators

Study Director: Luis A Muñoz, MD, Fundacion Universitaria de Ciencias de la Salud
Principal Investigator: Luis E Reyes, MD, Fundacion Universitaria de Ciencias de la Salud