Condition category
Respiratory
Date applied
03/01/2008
Date assigned
14/02/2008
Last edited
02/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michael Tamm

ORCID ID

Contact details

University Hospital Basel
Clinic of Pulmonary Medicine and Respiratory Cell Research
Petersgraben 4
Basel
4031
Switzerland
+ 41 61 265 5184
dstolz@uhbs.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The use of propofol for sedation in flexible bronchoscopy is associated with a mean low saturation within 2% of that of the combination of midazolam and hydrocodone, or better.

Ethics approval

Ethics Committee of Basel (Ethikkommission Beider Basel), approved on 29 August 2006 (ref: 19603)

Study design

Prospective single-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Sedation for flexible bronchoscopy

Intervention

Patients will be randomly assigned to propofol (intravenous; iv) or the combination of midazolam and hydrocodone (iv) for sedation during flexible bronchoscopy. The doses of propofol and midazolam vary among the patients, depending on the level of sedation obtained. Hydrocodone will be used in the standard dose of 5 mg iv.

Intervention type

Drug

Phase

Not Specified

Drug names

Propofol, midazolam and hydrocodone

Primary outcome measures

1. Mean lowest oxygen saturation during the procedure
2. Median patient overall well-being (comfort) at 1 hour after the procedure

Secondary outcome measures

1. Duration of the procedure
2. Hemodynamic parameters during and after the procedure
3. Cough scores, as assessed by a visual analogue scale by patients, nurses and physicians 2 hours after the procedure
4. Patient discomfort
5. Willigness to undergo a repeated procedure, assessed by a visual analogue scale 2 hours after the procedure
6. Fear of undergoing a repeated procedure, assessed by a visual analogue scale 2 hours after the procedure
7. Number (percentage) of complications (desaturation >90%, Chin-support, mild bledding, severe bleeding, nasopharyngeal-tube use, intubation, Intensive Care Unit [ICU] need post-bronchoscopy, hypotension, pneumothorax, death) assessed by the study physician during and up to 24 hours after the procedure
8. Supplemental lidocaine doses, assessed by the nurse team and study physician during the procedure, as judged by the bronchosopist
9. Medication doses, assessed by the nurse team and study physician during the procedure, as judged by the bronchoscopist
10. Median patient overall well-being (comfort) at 2 hours after the procedure

Overall trial start date

02/01/2008

Overall trial end date

31/03/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age >18 years
2. Need for flexible bronchoscopy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Invasive mechanical ventilation
2. Known allergy or intolerance to midazolam, hydrocodone or propofol
3. Inability to provide informed consent

Recruitment start date

02/01/2008

Recruitment end date

31/03/2008

Locations

Countries of recruitment

Switzerland

Trial participating centre

University Hospital Basel
Basel
4031
Switzerland

Sponsor information

Organisation

University Hospital Basel (Switzerland)

Sponsor details

c/o Prof Michael Tamm
Clinic of Pulmonary Medicine and Respiratory Cell Research
Petersgraben 4
Basel
4031
Switzerland
+ 41 61 265 5184
dstolz@uhbs.ch

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Clinic of Pulmonary Medicine and Respiratory Cell Research, University Hospital Basel (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19386684

Publication citations

  1. Results

    Stolz D, Kurer G, Meyer A, Chhajed PN, Pflimlin E, Strobel W, Tamm M, Propofol versus combined sedation in flexible bronchoscopy: a randomised non-inferiority trial., Eur. Respir. J., 2009, 34, 5, 1024-1030, doi: 10.1183/09031936.00180808.

Additional files

Editorial Notes