Bronchoscopy and Bispectral Index (BIS) - Guided Sedation - Full Text View

Sponsors and Collaborators:	University Hospital, Geneva Centre Valaisan de Pneumologie, CH-3960Montana
Information provided by:	University Hospital, Geneva
ClinicalTrials.gov Identifier:	NCT00839371

Purpose

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	Intervention	Phase
Bronchoscopy	Drug: Propofol Drug: Midazolam	Phase IV

Drug Information available for: Midazolam Midazolam maleate Midazolam hydrochloride Propofol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Bronchoscopy Under Titrated Sedation With Propofol or Midazolam: a Randomized Trial.

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:

electroencephalographic (BIS) and functional cognitive recovery [ Time Frame: 24h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary endpoints are patient subjective tolerance, operator evaluation of patient tolerance and cardiopulmonary adverse events [ Time Frame: 24h ] [ Designated as safety issue: No ]
respiratory depression, hypotension [ Time Frame: 24h ] [ Designated as safety issue: Yes ]

Enrollment:	84
Study Start Date:	January 2005
Study Completion Date:	December 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Midazolam: Active Comparator i.v. midazolam titration until adequate depth of sedation	Drug: Midazolam i.v. midazolam titration until adequate depth of sedation
Propofol: Active Comparator i.v. propofol titration until adequate depth of sedation	Drug: Propofol i.v. propofol titration until adequate depth of sedation

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Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00839371

Locations

Switzerland
Centre Valaisan de Pneumologie
Montana, Switzerland, CH-3960

Sponsors and Collaborators

University Hospital, Geneva

Centre Valaisan de Pneumologie, CH-3960Montana

Investigators

Principal Investigator:

Gregory Clark, MD

La Chaud de Fonds

More Information

No publications provided

Responsible Party:	Centre Valaisan de Pneumologie ( Jean-Marie Tschopp )
Study ID Numbers:	HUG-CVP 2007-1
Study First Received:	February 6, 2009
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00839371 History of Changes
Health Authority:	Switzerland: Ethikkommission; Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:

bispectral analysis
bronchoscopy
midazolam

propofol
recovery
sedation

Study placed in the following topic categories:

Anesthetics, Intravenous
Neurotransmitter Agents
Tranquilizing Agents
Anesthetics, General
Hypnotics and Sedatives
Psychotropic Drugs

Adjuvants, Immunologic
Central Nervous System Depressants
Anesthetics
Anti-Anxiety Agents
Propofol
Midazolam

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics
Central Nervous System Depressants
Midazolam

Pharmacologic Actions
Adjuvants, Anesthesia
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Propofol
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 06, 2009