Text Size

Bronchoscopy and Bispectral Index (BIS) - Guided Sedation

This study has been completed.
Sponsor:
Collaborator:
Centre Valaisan de Pneumologie, CH-3960Montana
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00839371
First received: February 6, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bronchoscopy Under Titrated Sedation With Propofol or Midazolam: a Randomized Trial.

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

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
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

  Show Detailed Description

  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 by University Hospital, Geneva

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by University Hospital, Geneva:
bispectral analysis
bronchoscopy
midazolam
 propofol
recovery
sedation

Additional relevant MeSH terms:
Midazolam
Propofol
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
 Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 13, 2013