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Bronchoscopy and Bispectral Index (BIS) - Guided Sedation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00839371
Recruitment Status : Completed
First Posted : February 9, 2009
Last Update Posted : February 9, 2009
Centre Valaisan de Pneumologie, CH-3960Montana
Information provided by:
University Hospital, Geneva

Brief 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.

Condition or disease Intervention/treatment Phase
Bronchoscopy Drug: Propofol Drug: Midazolam Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bronchoscopy Under Titrated Sedation With Propofol or Midazolam: a Randomized Trial.
Study Start Date : January 2005
Actual Primary Completion Date : November 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Midazolam
i.v. midazolam titration until adequate depth of sedation
Drug: Midazolam
i.v. midazolam titration until adequate depth of sedation

Active Comparator: Propofol
i.v. propofol titration until adequate depth of sedation
Drug: Propofol
i.v. propofol titration until adequate depth of sedation

Primary Outcome Measures :
  1. electroencephalographic (BIS) and functional cognitive recovery [ Time Frame: 24h ]

Secondary Outcome Measures :
  1. The secondary endpoints are patient subjective tolerance, operator evaluation of patient tolerance and cardiopulmonary adverse events [ Time Frame: 24h ]
  2. respiratory depression, hypotension [ Time Frame: 24h ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • patients scheduled for bronchoscopy
  • ASA I to III
  • age between 18 and 79 years
  • capacity of discernment

Exclusion Criteria:

  • visual and psychological problems that might interfere with psychometric testing
  • chronic obstructive pulmonary disease with FEV1 < 50% predicted
  • need for an airway intubation or laryngeal mask insertion
  • fever or other signs of systemic infection
  • hemodynamic instability defined as a resting heart rate (HR) < 60 or ≥ 120 and/or a systolic blood pressure (BP) < 100 or > 180 mmHg
  • significant liver disease and documented soy allergy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00839371

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Centre Valaisan de Pneumologie
Montana, Switzerland, CH-3960
Sponsors and Collaborators
University Hospital, Geneva
Centre Valaisan de Pneumologie, CH-3960Montana
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Principal Investigator: Gregory Clark, MD La Chaud de Fonds

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jean-Marie Tschopp, Centre Valaisan de Pneumologie Identifier: NCT00839371     History of Changes
Other Study ID Numbers: HUG-CVP 2007-1
First Posted: February 9, 2009    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: February 2009
Keywords provided by University Hospital, Geneva:
bispectral analysis
Additional relevant MeSH terms:
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Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action