School Health Index

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

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Purpose
Eligibility
Location and Contact Information
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This study is currently recruiting patients.
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 protocole is to study the prophylactic effect of remifentanyl on bispectral index variation during a nociceptive stimuli.

Condition	Intervention
Nociceptive stimuli Sedated patient BIS variation	Drug: remifentanyl

MedlinePlus consumer health information

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

Further Study Details:

Primary Outcomes: BIS variation during bronchoalveolar lavage
Secondary Outcomes: Systolic blood pressure, diastolic blood pressure, heart rate viation
Expected Total Enrollment: 40

Study start: October 2004

Pain is difficult to estimate in ICU because most of the patients are sedated. Bispectral index could be helpfull in detecting this pain in ICU patients. Remifentanyl 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 remifentanyl 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 above, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

Sedated patient with mechanical ventilation with suspected nosocomial pneumonia

Exclusion Criteria:

Pace maker
Neurologic illness
Hemodynamic instability
Hypothermia

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00162591

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

France
Surgical ICU Bichat Claude Bernard, Paris, 75018, France; Recruiting

QUINTARD H Hervé, MD +33140258116 quintard@libertysurf.fr
QUINTARD H Hervé, MD, Principal Investigator

Study chairs or principal investigators

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

More Information

Study ID Numbers: P040201 AT/AT/04-116
Last Updated: September 12, 2005
Record first received: September 10, 2005
ClinicalTrials.gov Identifier: NCT00162591
Health Authority: France: Ethics Commitee of Paris Bichat Claude Bernard
ClinicalTrials.gov processed this record on 2005-09-13

Source: ClinicalTrials.gov
Cache Date: September 14, 2005

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

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School Health Index

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

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

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School Health Index

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

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Purpose

Eligibility

Location and Contact Information

More Information

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