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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2004 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00162591
First received: September 10, 2005
Last updated: November 21, 2005
Last verified: October 2004
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Bispectral Index as an Analgesia Monitoring in Severely Ill Patient: Effect of Remifentanyl

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier: NCT00162591     History of Changes
Other Study ID Numbers: P040201 AT/AT/04-116
Study First Received: September 10, 2005
Last Updated: November 21, 2005
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

Additional relevant MeSH terms:
Remifentanil
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on May 19, 2013