Bispectral Index as an Analgesia Monitoring in Severely Ill Patient: Effect of Remifentanyl - Full Text View

Bispectral Index as an Analgesia Monitoring in Severely Ill Patient: Effect of Remifentanyl

This study is currently recruiting participants.
Verified by Assistance Publique - Hôpitaux de Paris, October 2004

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00162591

Purpose

The aim of this protocol is to study the prophylactic effect of remifentanil on bispectral index variation during a nociceptive stimuli.

Condition	Intervention
Pain	Drug: remifentanyl

ChemIDplus related topics:

Remifentanil Remifentanil hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Bispectral Index as an Analgesia Monitoring in Severely Ill Patient: Effect of Remifentanyl

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

BIS variation during bronchoalveolar lavage

Secondary Outcome Measures:

Systolic blood pressure, diastolic blood pressure, heart rate viation

Estimated Enrollment:	40
Study Start Date:	October 2004

Detailed Description:

Pain is difficult to estimate in ICU because most of the patients are sedated. Bispectral index could be helpful in detecting this pain in ICU patients. Remifentanil is a morphinomimetic product with short half life that could be interesting for short nociceptive stimuli, as bronchoalveolar lavage.

The purpose of this study is to evaluate the impact of remifentanil infusion on bispectral index (BIS) variations during bronchoalveolar lavage.

It is a prospective, double blind study, versus placebo on 40 sedated and critically ill patients.

The hypothesis is that BIS can study analgesia in sedated patient.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Sedated patient with mechanical ventilation with suspected nosocomial pneumonia

Exclusion Criteria:

Pace maker
Neurologic illness
Hemodynamic instability
Hypothermia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162591

Contacts


Contact: QUINTARD h Hervé, MD	+33140258816	quintard@libertysurf.fr

Locations


France
	Surgical ICU Bichat Claude Bernard	Recruiting
	Paris, France, 75018
	Contact: QUINTARD H Hervé, MD +33140258116 quintard@libertysurf.fr
	Principal Investigator: QUINTARD H Hervé, MD

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators


Principal Investigator:	QUINTARD H Hervé, MD	Surgical ICU Bichat Claude Bernard (Paris, France)

More Information

Study ID Numbers:	P040201 AT/AT/04-116
First Received:	September 10, 2005
Last Updated:	November 21, 2005
ClinicalTrials.gov Identifier:	NCT00162591
Health Authority:	France: Ethics Commitee of Paris Bichat Claude Bernard

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Bispectral index

sedation

remifentanyl

Bronchoalveolar lavage

Intensive care

Nociceptive stimuli

Sedated patient

BIS variation

Study placed in the following topic categories:

Remifentanil

Pain

Additional relevant MeSH terms:

Anesthetics, Intravenous

Physiological Effects of Drugs

Central Nervous System Depressants

Anesthetics

Pharmacologic Actions

Sensory System Agents

Anesthetics, General

Therapeutic Uses

Hypnotics and Sedatives

Analgesics

Peripheral Nervous System Agents

Central Nervous System Agents

Analgesics, Opioid

ClinicalTrials.gov processed this record on September 19, 2008