Propofol versus midazolam in medical thoracoscopy

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN95930113

Enrollment

Registered

2011-08-31

Start date

2011-05-01

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracoscopy in pleural effusion/pulmonary disease Respiratory Thoracoscopy in pleural effusion/pulmonary disease

Interventions

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 continuo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 or older 2. Patients undergoing thoracoscopy

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Mean lowest oxygen saturation during the procedure	—

Secondary

Measure	Time frame
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 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	—

Measure

Time frame

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 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

—

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026