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

NCT ID: NCT00162591

Last Updated: 2005-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pain

Keywords

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Bispectral index sedation remifentanyl Bronchoalveolar lavage Intensive care Nociceptive stimuli Sedated patient BIS variation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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remifentanyl

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Sedated patient with mechanical ventilation with suspected nosocomial pneumonia

Exclusion Criteria

* Pace maker
* Neurologic illness
* Hemodynamic instability
* Hypothermia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Principal Investigators

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QUINTARD H Hervé, MD

Role: PRINCIPAL_INVESTIGATOR

Surgical ICU Bichat Claude Bernard (Paris, France)

Locations

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Surgical ICU Bichat Claude Bernard

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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QUINTARD h Hervé, MD

Role: CONTACT

Phone: +33140258816

Email: [email protected]

Facility Contacts

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QUINTARD H Hervé, MD

Role: primary

References

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Quintard H, Pavlakovic I, Mantz J, Ichai C. Adjunctive remifentanil infusion in deeply sedated and paralyzed ICU patients during fiberoptic bronchoscopy procedure: a prospective, randomized, controlled study. Ann Intensive Care. 2012 Jul 16;2(1):29. doi: 10.1186/2110-5820-2-29.

Reference Type DERIVED
PMID: 22800647 (View on PubMed)

Other Identifiers

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P040201 AT/AT/04-116

Identifier Type: -

Identifier Source: org_study_id