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

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ClinicalTrials.gov Identifier: NCT00162591
Recruitment Status : Unknown
Verified October 2004 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : September 13, 2005
Last Update Posted : November 22, 2005
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment Phase
Pain Drug: remifentanyl Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Bispectral Index as an Analgesia Monitoring in Severely Ill Patient: Effect of Remifentanyl
Study Start Date : October 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. BIS variation during bronchoalveolar lavage

Secondary Outcome Measures :
  1. Systolic blood pressure, diastolic blood pressure, heart rate viation


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00162591     History of Changes
Other Study ID Numbers: P040201 AT/AT/04-116
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: November 22, 2005
Last Verified: October 2004

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
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics