Condition category
Respiratory
Date applied
17/06/2011
Date assigned
31/08/2011
Last edited
04/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 4

Trial website

Contact information

Type

Scientific

Primary contact

Prof Daiana Stolz

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

151/11

Study information

Scientific title

Propofol versus midazolam in medical thoracoscopy: a randomised non-inferiority trial

Acronym

Study hypothesis

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

Basel Ethics Committee, Switzerland, 23 June 2011

Study design

Prospective randomised non-inferiority single centre 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

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 names

Hydrocodon, midazolam, pethidine, propofole

Primary outcome measures

Mean lowest oxygen saturation during the procedure

Secondary outcome measures

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

Overall trial start date

01/05/2011

Overall trial end date

31/08/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged 18 or older
2. Patients undergoing thoracoscopy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant 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

Recruitment start date

01/05/2011

Recruitment end date

31/08/2013

Locations

Countries of recruitment

Switzerland

Trial participating centre

University Hospital Basel
Basel
4031
Switzerland

Sponsor information

Organisation

University Hospital Basel (Switzerland)

Sponsor details

Clinic of Pneumology and Respiratory Cell Research
c/o Prof. Dr. Michael Tamm
Petersgraben 4
Basel
4031
Switzerland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Basel (Switzerland) - Clinic of Pneumology and Respiratory Cell Research

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

Publication citations

Additional files

Editorial Notes