Lung Cancer Clinical Trial
Official title:
Target-controlled Versus Manually-controlled Propofol Sedation in Flexible Bronchoscopy. A Randomized Non-inferiority Trial.
After randomization, the subjects undergo flexible bronchoscopy either with fractionated propofol administration or with propofol-TCI. Measurement of blood pressure, heart rate, oxygen saturation, and oxygen requirement are measured continuously during the procedure and thereafter. Cumulative propofol dose, and induction, procedure, and recovery time are noted continuously during and after the procedure.
In daily clinical praxis, propofol sedation is given manually in repeated doses
(fractionated) by a specially-trained nurse in attendance of the bronchoscopist. But,
fractionated propofol administration (FPA) may lead to oversedation and enhanced side
effects (oxygen desaturation and arterial hypotension), as a stable plasma concentration of
propofol is not maintainable. In contrast to FPA, continuous infusions of propofol are
commonly used to induce and maintain long-term sedation in intensive care units and general
anesthesia. Recently, continuous propofol infusion for sedation in bronchoscopy has been
shown comparable to FPA in terms of safety and efficacy. Generally, infusion devices can be
manually controlled (MCI) or target-controlled (TCI). In the latter, the physician sets a
target blood concentration and the computerized infusion device makes the necessary changes
to the infusion rate.
The objective of this study is to compare propofol TCI with FPA in flexible bronchoscopy
concerning patient safety and sedation quality.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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