NCT00839371

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2009

Completed
Last Updated

February 9, 2009

Status Verified

February 1, 2009

Enrollment Period

2.8 years

First QC Date

February 6, 2009

Last Update Submit

February 6, 2009

Conditions

Bronchoscopy

Keywords

bispectral analysisbronchoscopymidazolampropofolrecoverysedation

Outcome Measures

Primary Outcomes (1)

  • electroencephalographic (BIS) and functional cognitive recovery

    24h

Secondary Outcomes (2)

  • The secondary endpoints are patient subjective tolerance, operator evaluation of patient tolerance and cardiopulmonary adverse events

    24h

  • respiratory depression, hypotension

    24h

Study Arms (2)

Midazolam

ACTIVE COMPARATOR

i.v. midazolam titration until adequate depth of sedation

Drug: Midazolam

Propofol

ACTIVE COMPARATOR

i.v. propofol titration until adequate depth of sedation

Drug: Propofol

Interventions

PropofolDRUG

i.v. propofol titration until adequate depth of sedation

Propofol
MidazolamDRUG

i.v. midazolam titration until adequate depth of sedation

Midazolam

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Valaisan de Pneumologie

Montana, CH-3960, Switzerland

Location

Related Publications (1)

  • Clark G, Licker M, Younossian AB, Soccal PM, Frey JG, Rochat T, Diaper J, Bridevaux PO, Tschopp JM. Titrated sedation with propofol or midazolam for flexible bronchoscopy: a randomised trial. Eur Respir J. 2009 Dec;34(6):1277-83. doi: 10.1183/09031936.00142108. Epub 2009 May 14.

    PMID: 19443532DERIVED

MeSH Terms

Interventions

PropofolMidazolam

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Gregory Clark, MD

    La Chaud de Fonds

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 6, 2009

First Posted

February 9, 2009

Study Start

January 1, 2005

Primary Completion

November 1, 2007

Study Completion

December 1, 2007

Last Updated

February 9, 2009

Record last verified: 2009-02

Locations

CH(1)