Propofol versus midazolam/hydrocodone for sedation in flexible bronchoscopy: Safety and patient comfort - a non-inferiority trial

ISRCTN	ISRCTN99754241
DOI	https://doi.org/10.1186/ISRCTN99754241
Protocol serial number	N/A
Sponsor	University Hospital Basel (Switzerland)
Funder	Clinic of Pulmonary Medicine and Respiratory Cell Research, University Hospital Basel (Switzerland)

Submission date: 03/01/2008
Registration date: 14/02/2008
Last edited: 02/11/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Michael Tamm
Scientific

University Hospital Basel
Clinic of Pulmonary Medicine and Respiratory Cell Research
Petersgraben 4
Basel
4031
Switzerland

Phone	+ 41 61 265 5184
Email	dstolz@uhbs.ch

Study information

Primary study design	Interventional
Study design	Prospective single-blind randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	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(s)	Ethics Committee of Basel (Ethikkommission Beider Basel), approved on 29 August 2006 (ref: 19603)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Propofol, midazolam and hydrocodone
Primary outcome measure(s)	1. Mean lowest oxygen saturation during the procedure 2. Median patient overall well-being (comfort) at 1 hour after the procedure
Key secondary outcome measure(s)	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
Completion date	31/03/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	200
Key inclusion criteria	1. Age >18 years 2. Need for flexible bronchoscopy
Key exclusion criteria	1. Invasive mechanical ventilation 2. Known allergy or intolerance to midazolam, hydrocodone or propofol 3. Inability to provide informed consent
Date of first enrolment	02/01/2008
Date of final enrolment	31/03/2008

Locations

Countries of recruitment

Switzerland

Study participating centre

University Hospital Basel

Basel
4031
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes