Propofol versus midazolam/hydrocodone for sedation in flexible bronchoscopy: Safety and patient comfort - a non-inferiority trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN99754241

Enrollment

200

Registered

2008-02-14

Start date

2008-01-02

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

Sedation for flexible bronchoscopy Respiratory

Interventions

Patients will be randomly assigned to propofol (intravenous

iv) or the combination of midazolam and hydrocodone (iv) for sedation during flexible bronchoscopy. The doses of propofol and midazolam vary among the patients, depending on the level of sedation obta

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age >18 years 2. Need for flexible bronchoscopy

Exclusion criteria

Exclusion criteria: 1. Invasive mechanical ventilation 2. Known allergy or intolerance to midazolam, hydrocodone or propofol 3. Inability to provide informed consent

Design outcomes

Primary

Measure	Time frame
1. Mean lowest oxygen saturation during the procedure 2. Median patient overall well-being (comfort) at 1 hour after the procedure	—

Secondary

Measure	Time frame
1. Duration of the procedure 2. Hemodynamic parameters during and after the procedure 3. Cough scores, as assessed by a visual analogue scale by patients, nurses and physicians 2 hours after the procedure 4. Patient discomfort 5. Willigness to undergo a repeated procedure, assessed by a visual analogue scale 2 hours after the procedure 6. Fear of undergoing a repeated procedure, assessed by a visual analogue scale 2 hours after the procedure 7. Number (percentage) of complications (desaturation >90%, Chin-support, mild bledding, severe bleeding, nasopharyngeal-tube use, intubation, Intensive Care Unit [ICU] need post-bronchoscopy, hypotension, pneumothorax, death) assessed by the study physician during and up to 24 hours after the procedure 8. Supplemental lidocaine doses, assessed by the nurse team and study physician during the procedure, as judged by the bronchosopist 9. Medication doses, assessed by the nurse team and study physician during the procedure, as judged by the bronchoscopist 10. Median patient overall well-being (comfort) at 2 hours after the procedure	—

Measure

Time frame

1. Duration of the procedure 2. Hemodynamic parameters during and after the procedure 3. Cough scores, as assessed by a visual analogue scale by patients, nurses and physicians 2 hours after the procedure 4. Patient discomfort 5. Willigness to undergo a repeated procedure, assessed by a visual analogue scale 2 hours after the procedure 6. Fear of undergoing a repeated procedure, assessed by a visual analogue scale 2 hours after the procedure 7. Number (percentage) of complications (desaturation >90%, Chin-support, mild bledding, severe bleeding, nasopharyngeal-tube use, intubation, Intensive Care Unit [ICU] need post-bronchoscopy, hypotension, pneumothorax, death) assessed by the study physician during and up to 24 hours after the procedure 8. Supplemental lidocaine doses, assessed by the nurse team and study physician during the procedure, as judged by the bronchosopist 9. Medication doses, assessed by the nurse team and study physician during the procedure, as judged by the bronchoscopist 10. Median patient overall well-being (comfort) at 2 hours after the procedure

—

Countries

Switzerland

Outcome results

None listed

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