Propofol versus midazolam in medical thoracoscopy

ISRCTN	ISRCTN95930113
DOI	https://doi.org/10.1186/ISRCTN95930113
Protocol serial number	151/11
Sponsor	University Hospital Basel (Switzerland)
Funder	University Hospital Basel (Switzerland)

Submission date: 17/06/2011
Registration date: 31/08/2011
Last edited: 11/07/2017

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Propofol is a drug that is used to slow the activity of the brain and nervous system (sedative). Studies have shown propofol to be safe and effective as a sedative for bronchoscopic procedures, where an instrument (bronchoscope) is inserted into the airways to look at the inside of the airways. The aim of this study is to assess the feasibility and safety of using propofol for conscious sedation in medical thoracoscopy, where a thin, flexible viewing tube (called a thoracoscope) is inserted through a small cut in the chest.

Who can participate?
Patients aged 18 or older undergoing thoracoscopy

What does the study involve?
Participants are randomly allocated to be sedated with either propofol or midazolam.
All participants also receive hydrocodone and pethidine intravenously (delivered into a vein) and supplemental oxygen is offered via a face mask. Diagnostic and treatment procedures are performed as needed. Blood parameters, sedation, duration of thoracoscopy, indication, procedures and complications are noted during the procedure.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University Hospital Basel (Switzerland)

When is the study starting and how long is it expected to run for?
May 2011 to August 2013

Who is funding the study?
University Hospital Basel (Switzerland)

Who is the main contact?
Prof. Daiana Stolz

Contact information

Prof Daiana Stolz
Scientific

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

Study information

Primary study design	Interventional
Study design	Prospective randomised non-inferiority single-centre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Propofol versus midazolam in medical thoracoscopy: a randomised non-inferiority trial
Study objectives	Propofol is a sedative-hypnotic with a rapid onset of action coupled with smooth and rapid recovery. Studies using it as a sedative agent for bronchoscopic procedures have shown propofol to be safe and effective. Hardly any data exist about the feasibility and safety of propofol for conscious sedation in medical thoracoscopy.
Ethics approval(s)	Basel Ethics Committee, Switzerland, 23/06/2011
Health condition(s) or problem(s) studied	Thoracoscopy in pleural effusion/pulmonary disease
Intervention	Patients will be randomly assigned to either propofol or midazolam. Patients assigned to the propofol group will receive an initial bolus of intravenous propofol, immediately followed by the continuous infusion. In case of inadequate sedation, a bolus of propofol will be given and the infusion rate will be increased. In case of apnoea, hypoxemia or hypotension, the continuous infusion can be reduced or completely stopped at all times. Midazolam will be titrated in order to achieve adequate conscious sedation (onset of ptosis). All patients will receive hydrocodone and pethidine intravenously. Supplemental oxygen will be offered via a face mask to all patients. Diagnostic and therapeutic procedures will be performed dependent upon the clinical indication. Haemodynamic parameters, sedation, duration of thoracoscopy, indication, procedures and complications will be noted during the procedure.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Hydrocodone, midazolam, pethidine, propofol
Primary outcome measure(s)	Mean lowest oxygen saturation during the procedure
Key secondary outcome measure(s)	1. Duration of the procedure 2. Mean lowest breathing rate during the procedure 3. Mean highest carbon dioxide tension during the procedure 4. Mean lowest systolic blood pressure, mean lowest and mean highest heart rate during the procedure 5. Number (percentage) of complications during the procedure assessed by the study physician during the procedure 5.1. Oxygen desaturation less than or equal to 90 %, need for chin-support 5.2. Need for nasopharyngeal or oropharyngeal airway insertion 5.3. Need for intubation 5.4. Hypotension with a systolic blood pressure of < 90 mmHg 5.5. Minor or major bleeding 5.6. Intensive Care Unit [ICU] need post-thoracoscopy 5.7. Need to abort thoracoscopy 5.8. Death 6. Number (percentage) of complications following the procedure assessed by the study physician up to 4 weeks after the procedure 6.1. Uncontrollable pain 6.2. Subcutaneous emphysema 6.3. Fever > 38.5°C 6.4. Drain site infection 6.5. Empyema 6.6. Pleuro-cutaneous fistula 6.7. Need for intubation 6.8. Bleeding 6.9. Intensive Care Unit [ICU] need 6.10. Need for insertion of an additional chest tube 6.11. Need for re-thoracoscopy 6.12. Death 7. Total dose of propofol and midazolam, respectively; dose of propofol and midazolam per kilogram body weight; dose of propofol and midazolam per kilogram body weight and per minute 8. Medication doses of hydrocodone and pethidine (meperidine) 9. Cough scores, as assessed by a visual analogue scale by nurses during procedure 10. Patient discomfort 24 hours after the procedure 11. Willingness to undergo a repeated procedure, assessed by a visual analogue scale 24 hours after the procedure 12. Fear of undergoing a repeated procedure, assessed by a visual analogue scale 24 hours after the procedure
Completion date	31/08/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	90
Key inclusion criteria	1. Patients aged 18 or older 2. Patients undergoing thoracoscopy
Key exclusion criteria	1. Known allergy to propofol, midazolam, hydrocodone or pethidine 2. Mental disorder preventing appropriate judgment concerning study participation 3. Pregnancy and breast-feeding 4. Intubated patients
Date of first enrolment	01/05/2011
Date of final enrolment	31/08/2013

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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/07/2017: Plain English summary added.