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Clinical Trials/NCT00162591
NCT00162591
Unknown
Not Applicable

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country40 target enrollmentOctober 2004
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
40
Locations
1
Primary Endpoint
BIS variation during bronchoalveolar lavage
Last Updated
20 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
October 2004
End Date
TBD
Last Updated
20 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Sedated patient with mechanical ventilation with suspected nosocomial pneumonia

Exclusion Criteria

  • Pace maker
  • Neurologic illness
  • Hemodynamic instability
  • Hypothermia

Outcomes

Primary Outcomes

BIS variation during bronchoalveolar lavage

Secondary Outcomes

  • Systolic blood pressure, diastolic blood pressure, heart rate viation

Study Sites (1)

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