NCT00162591

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
Last Updated

November 22, 2005

Status Verified

October 1, 2004

First QC Date

September 10, 2005

Last Update Submit

November 21, 2005

Conditions

Pain

Keywords

Bispectral indexsedationremifentanylBronchoalveolar lavageIntensive careNociceptive stimuliSedated patientBIS variation

Outcome Measures

Primary Outcomes (1)

  • BIS variation during bronchoalveolar lavage

Secondary Outcomes (1)

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

Interventions

remifentanylDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sedated patient with mechanical ventilation with suspected nosocomial pneumonia

You may not qualify if:

  • Pace maker
  • Neurologic illness
  • Hemodynamic instability
  • Hypothermia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surgical ICU Bichat Claude Bernard

Paris, 75018, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 22800647DERIVED

MeSH Terms

Conditions

Pain

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • QUINTARD H Hervé, MD

    Surgical ICU Bichat Claude Bernard (Paris, France)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

QUINTARD h Hervé, MD

CONTACT

+33140258816quintard@libertysurf.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 13, 2005

Study Start

October 1, 2004

Last Updated

November 22, 2005

Record last verified: 2004-10

Locations

FR(1)