Effect of two different forms of propofol administration on sedation during bronchoscopy
Not Applicable
Completed
- Conditions
- Sedation during flexible bronchoscopyNot Applicable
- Registration Number
- ISRCTN56531234
- Lead Sponsor
- Rechts der Isar Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
Patients scheduled for diagnostic or interventional bronchoscopy with an estimated duration >10 min
Exclusion Criteria
1. Age <18 years
2. Contraindications to propofol
3. Emergency procedures
4. Pregnancy
5. Cystic fibrosis
6. Mandatory ventilation
7. Acute respiratory insufficiency
8. Tachycardia >125 bpm
9. Tachycardic arrhythmias
10. Acute coronary syndrome
11. Severe heart failure
12. Septic shock
13. Severe hepatic impairment
14. Systolic blood pressure <90 mmHg
15. SpO2 < 90% without supplemental oxygen at presentation and body mass index > 40 kg/m²
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Level of sedation measured with Response and State Entropy (RE+SE), expressed as mean ± SEM representing the baseline starting points, the induction period until loss of consciousness (LOC), the LOC itself as a timepoint, and the procedure until the end of bronchoscopy<br> 2. Sedation quality measured using a questionnaire to be completed by proceduralists and assisting nurses right after examination. Sedation quality could be rated using a grading system from Grade 1 = Patient was very calm, excellent working conditions” up to Grade 6 Patient was uneasy, not good working conditions. Expressed as numbers n and percentage<br> 3. Total amount of propofol, and duration until LOC and duration of the procedure, expressed as mean ± SEM, measured using a timer function within the recording software, starting right before the sedation starts and ending 10 min after bronchoscopy ends<br>
- Secondary Outcome Measures
Name Time Method Adverse effects of the sedation protocol, i.e. heart rate >125 bpm and <50 bpm, blood pressure <90 mmHg, <80% and >120% of baseline, SpO2 <90% and <80% for >10 sec and respiratory rate <8/min, expressed as number (n) and percentage (%), measured using a monitoring device and software recording every vital sign in real-time every second for HR and SpO2 and every 2.5 min for respiratory rate during the whole procedure