This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Bronchoscopy and Bispectral Index (BIS) - Guided Sedation

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

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
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.

Resource links provided by NLM:

Further study details as provided by University Hospital, Geneva:

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

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

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


Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00839371

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jean-Marie Tschopp, Centre Valaisan de Pneumologie Identifier: NCT00839371     History of Changes
Other Study ID Numbers: HUG-CVP 2007-1
Study First Received: February 6, 2009
Last Updated: February 6, 2009

Keywords provided by University Hospital, Geneva:
bispectral analysis

Additional relevant MeSH terms:
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 processed this record on August 21, 2017