drugset / Trial / NCT00789815

Bispectral Index-guided Sedation for Flexible Bronchoscopy

NCT00789815

Phase 4 Completed 500 enrolled Chang Gung Memorial Hospital
RandomizedParallel-groupOpen-labelHealth-services research

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.

Timeline

Start
2008-04
Primary completion
2009-09
Completion
2009-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Midazolam Small molecule 2 mg Intravenous
Subject Propofol Small molecule 3 mg/kg Intravenous
Subject Propofol Small molecule 12 mg/kg Intravenous
Comparator Alfentanil Other / unclassified 5 ug/kg

Indications

No indication recorded.