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

NCT ID: NCT01746641

Last Updated: 2012-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Pain

Keywords

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Remifentanil Propofol Sedation Endoscopy Gastroenterology Target controlled infusion effect site

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Interventions

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Remifentanil

Intervention Type DRUG

Propofol

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de San Jose

OTHER

Sponsor Role collaborator

Fundación Universitaria de Ciencias de la Salud

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luis A Muñoz, MD

Role: STUDY_DIRECTOR

Fundacion Universitaria de Ciencias de la Salud

Luis E Reyes, MD

Role: PRINCIPAL_INVESTIGATOR

Fundacion Universitaria de Ciencias de la Salud

Locations

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Fundación Universitaria de Ciencias de la Salud

Bogotá, Bogota D.C., Colombia

Site Status

Countries

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Colombia

Other Identifiers

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Acta No. 197

Identifier Type: -

Identifier Source: org_study_id