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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
78
Flexible bronchoscopy for diagnosis of lung cancer, sarcoidosis or interstitial pneumonia in moderate sedation with propofol;
Continuous measurement of oxygen saturation;
Measurement of non-invasive blood pressure every 3 minutes
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland
Mean arterial oxygen saturation
From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
Time frame: During bronchoscopy
Number of occasions with recorded an oxygen saturation of < 90%
From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
Time frame: During bronchoscopy
Number of an oxygen desaturation of > 4% from baseline
From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
Time frame: During bronchoscopy
Number of occasions with a systolic blood pressure < 90 mmHg during bronchoscopy, maximum oxygen requirement,
From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
Time frame: During bronchoscopy
Frequency of dose adjustments
From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
Time frame: During bronchoscopy
Cumulative propofol dose
At time point when bronchoscope is removed (on average after 45 minutes)
Time frame: At end of bronchoscopy
Recovery time after bronchoscopy
Time frame: During 2 hours after bronchoscopy
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Report of dose adjustments und cumulative propofol dosage;
Recovery time after bronchoscopy from removal of bronchoscope to eye opening/answer to verbal stimuli (whatever comes first)