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

November 21, 2005 updated by: Assistance Publique - Hôpitaux de Paris
The aim of this protocol is to study the prophylactic effect of remifentanil on bispectral index variation during a nociceptive stimuli.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75018
        • Recruiting
        • Surgical ICU Bichat Claude Bernard
        • Contact:
        • Principal Investigator:
          • QUINTARD H Hervé, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Sedated patient with mechanical ventilation with suspected nosocomial pneumonia

Exclusion Criteria:

  • Pace maker
  • Neurologic illness
  • Hemodynamic instability
  • Hypothermia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
BIS variation during bronchoalveolar lavage

Secondary Outcome Measures

Outcome Measure
Systolic blood pressure, diastolic blood pressure, heart rate viation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

September 10, 2005

First Submitted That Met QC Criteria

September 10, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

November 22, 2005

Last Update Submitted That Met QC Criteria

November 21, 2005

Last Verified

October 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P040201 AT/AT/04-116

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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