Bispectral Index as an Analgesia Monitoring in Severely I... | NCT00162591

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

NCT00162591

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Nov 22, 2005Estimated

Enrollment

Phase

Not Applicable

Conditions

Pain

Interventions

remifentanyl

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2004

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 10, 2005

First Submission Date that Met QC Criteria

Sep 10, 2005

First Posted Date

Sep 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2005

Last Update Posted Date

Nov 22, 2005Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
remifentanyl	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
BIS variation during bronchoalveolar lavage

Secondary Outcomes

Measure	Description	Time Frame
Systolic blood pressure, diastolic blood pressure, heart rate viation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Sedated patient with mechanical ventilation with suspected nosocomial pneumonia

Exclusion Criteria:

Pace maker
Neurologic illness
Hemodynamic instability
Hypothermia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
QUINTARD h Hervé, MD	Contact	+33140258816		quintard@libertysurf.fr

Overall Officials

Name	Affiliation	Role
QUINTARD H Hervé, MD	Surgical ICU Bichat Claude Bernard (Paris, France)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Surgical ICU Bichat Claude Bernard	Recruiting	Paris		75018	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22800647	Derived	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.

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D011422	Propionates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals