Bolus administration versus continuous infusion of Propofol sedation in flexible bronchoscopy

ISRCTN	ISRCTN66129676
DOI	https://doi.org/10.1186/ISRCTN66129676
Protocol serial number	N/A
Sponsor	University Hospital Basel (Switzerland)
Funder	University Hospital Basel (Switzerland) - Clinic of Pneumology and Respiratory Cell Research

Submission date: 03/02/2011
Registration date: 03/05/2011
Last edited: 27/10/2014

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 Daiana Stolz
Scientific

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

Study information

Primary study design	Interventional
Study design	Prospective randomised non-inferiority single-centre study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Bolus administration versus continuous infusion of Propofol sedation in flexible bronchoscopy: a randomised non-inferiority trial
Study acronym	Propofol Study
Study objectives	Propofol is a sedative-hypnotic with a rapid onset of action coupled with smooth and rapid recovery. Multiple studies using it as a sedative agent for gastrointestinal endoscopic procedures have shown propofol to be safe and effective. More recently propofol-only sedation was shown to be a feasible and safe sedation method for bronchoscopic procedures as well. In the vast majority of studies an intermittent bolus technique was used. Hardly any data exists for the use of propofol using a continuous infusion as the sedation method in bronchoscopy. To show that for sedation in flexible bronchoscopy the use of propofol using a continuous infusion is associated with a incidence of complications within 5% of that of an intermittent bolus technique, or better.
Ethics approval(s)	The study protocol has been submitted to the Ethics Committee, Basel, Switzerland
Health condition(s) or problem(s) studied	Pulmonary disease diagnosis, need for flexible bronchoscopy
Intervention	Propofol continous infusion versus bolus for sedation in flexible bronchoscopy
Intervention type	Other
Primary outcome measure(s)	1. Number (percentage) of complications (oxygen desaturation less than or equal to 90% 2. Need for chin-support 3. Need for nasopharyngeal or oropharyngeal airway insertion 4. Need for intubation 5. Hypotension with a systolic blood pressure of less than 90 mmHg 6. Minor or major bleeding 7. Intensive Care Unit [ICU] need post-bronchoscopy 8. Pneumothorax 9. Need to abort bronchoscopy 10. Death These outcomes are assessed by the study physician during and up to 24 hours after the procedure
Key secondary outcome measure(s)	1. Total dose of propofol,dose of propofol per kilogram body weight and per minute 2. Duration of the procedure 3. Mean lowest oxygen saturation during the procedure 4. Mean lowest systolic blood pressure during the procedure 5. Hemodynamic parameters other than blood pressure during and after the procedure 6. Cough scores, as assessed by a Visual Analogue Scale (VAS) by patients, nurses and physicians during and 2 hours after the procedure 7. Patient discomfort 8. Median patient overall well-being (comfort) at 1 and 2 hours after the procedure 9. Willingness to undergo a repeated procedure, assessed by a VAS 2 hours after the procedure 10. Fear of undergoing a repeated procedure, assessed by a VAS 2 hours after the procedure 11. Supplemental lidocaine doses, assessed by the nurse team and study physician during the procedure, as judged by the bronchoscopist 12. Medication doses, assessed by the nurse team and study physician during the procedure, as judged by the bronchoscopist
Completion date	30/09/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	702
Key inclusion criteria	1. Patients aged 18 or older 2. Patients undergoing flexible bronchoscopy
Key exclusion criteria	1. Known allergy to propofol 2. Mental disorder preventing appropriate judgment concerning study participation 3. Pregnancy and breast-feeding 4. Intubated patients
Date of first enrolment	01/04/2011
Date of final enrolment	30/09/2012

Locations

Countries of recruitment

Switzerland

Study participating centre

Clinic of Pneumology and Respiratory Cell Research

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	01/02/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes