Flexible Bronchoscopy Clinical Trial
Official title:
Target-Controlled Infusion of Propofol for Flexible Bronchoscopy Sedation: Determining the Optimal Titrating Regimen
Flexible bronchoscopy (FB) sedation requires keeping sedative level in a narrow window to prevent over or under sedation. Sedative drug titration according to subjective adjustment by individual physician may cause unsteady drug concentration. Target controlled infusion (TCI) has been provided a precise pharmacokinetic control of propofol, direct control the effect side, (eg. Brain) concentration (Ce), and been applied in surgical anesthesia and variable procedure sedation. We designed this pilot study to evaluate the optimal regimen of TCI in FB sedation.
Propofol is ideal for bronchoscopy sedation because of its fast onset and quick recovery
effect. Our research and reports from different investigators demonstrate that patients
received propofol sedation recover fast with excellent satisfaction for bronchoscopy.
However, the amount of propofol for induction and maintenance is calculated simply by
patient's body weight and physicians' experience. For those non-anesthesiologists, who
perform sedative work outside the operating room, and inexperienced anesthesiologist without
fully considering the individual pharmacokinetic and pharmacodynamic differences may
generate unstable drug plasma concentration and increase cardio-respiration suppression.
Therefore, a manner which can assess and measure objectively individual pharmacokinetic
differences may improve the sedative quality and decrease the complication rate.
A model called "Target-controlled infusion"(TCI), built from massive pharmacokinetic samples
of propofol, could now give precise pharmacokinetic control. Several pharmacokinetic models
built-in in TCI, includes the Schnider model which use concentration of effect site (Ce, the
propofol concentration in the brain) as the sedative guide. The model integrates individual
variants of age, height, weight and gender to calculate the infusion profile to achieve
predetermined steady "target effect site concentration" (Cet). Because of the unique
consideration of individual pharmacokinetic variants and Ce targeting, TCI provides
predictable sedative level and is suitable for procedures requiring narrowing therapeutic
level. Beside general anesthesia, TCI has been applied in breast biopsy, upper
gastrointestinal endoscopic ultrasound and endoscopic retrograde cholangiopancreatography at
outpatient clinic. According to these evidences, there is potential role of TCI in
bronchoscopic sedation.
Based on current evidence and our experience, we design this study to evaluate the optimal
regimen for induction and procedure during bronchoscopy. We hope this study could provide
the more safety and efficient bronchoscopic sedation for patients and physicians.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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