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Bronchoscopy and Bispectral Index (BIS) - Guided Sedation

NCT00839371 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2009-02-09

No results posted yet for this study

Summary

Bronchoscopy is performed on a daily basis for diagnostic and therapeutic purposes. This procedure may cause anxiety and discomfort requiring the use of sedative drugs.

In this study the investigators titrate the administration of sedatives using bispectral analysis of the EEG. The investigators compared 2 drugs, propofol versus midazolam regarding patient subjective tolerance, recovery of brain function, safety and operator's satisfaction.

Conditions

  • Bronchoscopy

Interventions

DRUG

Propofol

i.v. propofol titration until adequate depth of sedation

DRUG

Midazolam

i.v. midazolam titration until adequate depth of sedation

Sponsors & Collaborators

  • Centre Valaisan de Pneumologie, CH-3960Montana

    collaborator UNKNOWN

  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Gregory Clark, MD · La Chaud de Fonds

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2007-11-30
Completion
2007-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00839371 on ClinicalTrials.gov