Bolus administration versus continuous infusion of Propofol sedation in flexible bronchoscopy

Bolus administration versus continuous infusion of Propofol sedation in flexible bronchoscopy: a randomised non-inferiority trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN66129676

Enrollment

702

Registered

2011-05-03

Start date

2011-04-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Pulmonary disease diagnosis, need for flexible bronchoscopy Respiratory pulmonary disease, need for flexible bronchoscopy

Interventions

Propofol continous infusion versus bolus for sedation in flexible bronchoscopy

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Known allergy to propofol 2. Mental disorder preventing appropriate judgment concerning study participation 3. Pregnancy and breast-feeding 4. Intubated patients

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Switzerland

Outcome results

None listed

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