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

Not Applicable

• Conditions: Pain

• Registration Number: NCT00162591
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2004-10
• Study Start: 2004-10
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-13
• Last Update Submitted: 2005-11-21
• Last Update Posted: 2005-11-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Sedated patient with mechanical ventilation with suspected nosocomial pneumonia

Exclusion Criteria

• Pace maker
• Neurologic illness
• Hemodynamic instability
• Hypothermia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
BIS variation during bronchoalveolar lavage

Secondary Outcome Measures

Name	Time	Method
Systolic blood pressure, diastolic blood pressure, heart rate viation

Trial Locations

Locations (1)

Surgical ICU Bichat Claude Bernard; 🇫🇷 Paris, France