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Sedation for Flexible Bronchoscopy and Real Time Endobronchial Ultrasound -A Comparison Between Bispectral Index-guided Sedation and Conventional Sedation
With the advances of flexible bronchoscopy, like metallic stent, electrocautery and real time endobronchial ultrasound, the complexity and duration of procedures are increasing. So, adequate sedation and analgesia is important for both patients and bronchoscopist. Clinical-judged midazolam administration is the current standard. However, midazolam is difficult to titrated and the clinical observations are not reliable sedative indices. Propofol is titrated easily because of its unique pharmacokinetics. Bispectral index (BIS), a real time monitor of depth-of-sedation, has been applied in general anesthesia. We design a BIS-guided propofol sedation for bronchoscopy. Through the combination of advantages of propofol and BIS, we hope to provide patients a more tolerable and safety sedation for bronchoscopy.
Details
| Lead sponsor | Chang Gung Memorial Hospital |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 500 |
| Start date | 2008-04 |
| Completion | 2009-09 |
Conditions
- Flexible Bronchoscopy
Interventions
- Bispectral index guide propofol infusion
- Clinical-judged midazolam administration
Primary outcomes
- The Number of Participants With Any Hypoxemia Event During Flexible Bronchoscopy — From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth
The hypoxemia event is defined as that when the oxyhemoglobin (SpO2) was less than 90% with any duration during the flexible bronchoscopy. - The Number of Participants With Any Hypotension Event During Flexible Bronchoscopy — From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth
The event of hypotension: when the systolic blood pressure (SBP) was less than 90mmHg with any duration. - The Global Tolerance for Flexible Bronchoscopy by Verbal Analogus Scale — After patients recovered orientation and before they leaved the scope room.
The global tolerance of the entire procedure was evaluated on a 10-point verbal analogous scale (VAS, 0: no bother, 10: worst intolerable).
Countries
Taiwan