Phase 4
N=500
Bispectral Index-guided Sedation for Flexible Bronchoscopy
Flexible Bronchoscopy
Bottom Line
View on ClinicalTrials.gov: NCT00789815 ↗Enrolled (actual)
500
Serious AEs
0.4%
Results posted
Apr 2010
Primary outcome: Primary: The Number of Participants With Any Hypoxemia Event During Flexible Bronchoscopy — 97; 88 participants — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bispectral index guide propofol infusion (Device); Clinical-judged midazolam administration (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chang Gung Memorial Hospital
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants With Any Hypoxemia Event During Flexible Bronchoscopy |
97; 88 | 0.05 |
| PRIMARY The Number of Participants With Any Hypotension Event During Flexible Bronchoscopy |
18; 11 | 0.05 |
| PRIMARY The Global Tolerance for Flexible Bronchoscopy by Verbal Analogus Scale |
0; 0 | 0.05 |
| SECONDARY The Number of Participants Causing Any Procedure Interference by the Patients' Movement During Flexible Bronchoscocopy |
33; 90 | 0.05 |
| SECONDARY The Number of Participants Causing Any Procedure Interference by Cough |
73; 110 | 0.05 |
| SECONDARY The Recovery Time to Orientation |
11.7; 30.0 | 0.05 |
| SECONDARY The Recovery Time to Ambulation |
30.0; 55.7 | 0.05 |
| SECONDARY Patients Willing Return if Repeated Bronchoscopy is Indicated. |
171; 169 | 0.05 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients (>18 years old) requiring elective flexible bronchoscopy or Real time endobronchial ultrasound with transbronchial needle aspiration.
Exclusion Criteria
- American Society of Anesthesiologists classification of physical status 4 and 5, including hepatic or renal failure, severe obstructive sleep apnea and severe chronic obstructive pulmonary disease.
- Significant Central nervous system disorders or other factors contributing to access consciousness difficultly.
- Allergic history to study drugs.
- A history of glaucoma in the midazolam arm.
Data sourced from ClinicalTrials.gov (NCT00789815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.