Fractionated Versus Target-controlled Propofol Administration in Bronchoscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Target-controlled Versus Manually-controlled Propofol Sedation in Flexible Bronchoscopy. A Randomized Non-inferiority Trial.

Conditions
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Lung Cancer, Sarcoidosis, Interstitial Pneumonia

Intervention / Treatment
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* Device: Flexible bronchoscopy in moderate sedation
* Device: Oxygen saturation
* Device: Blood pressure
* Device: Propofol dosage
* Device: Recovery time after bronchoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects undergoing a planned, ambulatory flexible bronchoscopy (for transbronchial lung biopsy or endobronchial ultrasound guided procedures) in moderate sedation, aged between 18 and 85 years Exclusion Criteria: History of solid organ or bone marrow transplantation with the use of an immunosuppressive therapy HIV infection on anti-retroviral therapy Alcohol consumption more than two standard drinks per day Use of illicit drugs (heroin, opiates) Any contraindication to use propofol for sedation (e.g. allergy) Body mass index > 35 kg/m2 Mental disorder preventing appropriate judgment concerning study participation Missing written patient's informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fractionated propofol administration<br>Flexible bronchoscopy in moderate sedation with fractionated propofol administrations: Patients receive an initial 20 mg of propofol, followed by a carefully titrated dose of10-20 mg propofol based on the clinical response. Continuous measurement of oxygen saturation Measurement of non-invasive blood pressure; Report of dose adjustments und cumulative propofol dosage; Recovery time after bronchoscopy | Device: Flexible bronchoscopy in moderate sedation<br>* Flexible bronchoscopy for diagnosis of lung cancer, sarcoidosis or interstitial pneumonia in moderate sedation with propofol;<br>Device: Oxygen saturation<br>* Continuous measurement of oxygen saturation;<br>Device: Blood pressure<br>* Measurement of non-invasive blood pressure every 3 minutes<br>Device: Propofol dosage<br>* Report of dose adjustments und cumulative propofol dosage;<br>Device: Recovery time after bronchoscopy<br>* Recovery time after bronchoscopy from removal of bronchoscope to eye opening/answer to verbal stimuli (whatever comes first)<br>|
| Experimental: Propofol-TCI<br>Flexible bronchoscopy in moderate sedation with TCI propofol perfusor: Flexible bronchoscopy is started after reaching the initial targeted effect-site concentration (Ce) of 2.5 μg/mL using the Schnider pharmacokinetic model described elsewhere. Thereafter, Ce is adjusted by increments of 0.2 μg/mL depending on the clinical effect, in order to maintain the required level of sedation. Continuous measurement of oxygen saturation Measurement of non-invasive blood pressure; Report of dose adjustments und cumulative propofol dosage; Recovery time after bronchoscopy The propofol-TCI perfusor is an active infusion system for fluid management. In the study, the Perfusor® Space of B. Braun AG, Melsungen is used exclusively. | Device: Flexible bronchoscopy in moderate sedation<br>* Flexible bronchoscopy for diagnosis of lung cancer, sarcoidosis or interstitial pneumonia in moderate sedation with propofol;<br>Device: Oxygen saturation<br>* Continuous measurement of oxygen saturation;<br>Device: Blood pressure<br>* Measurement of non-invasive blood pressure every 3 minutes<br>Device: Propofol dosage<br>* Report of dose adjustments und cumulative propofol dosage;<br>Device: Recovery time after bronchoscopy<br>* Recovery time after bronchoscopy from removal of bronchoscope to eye opening/answer to verbal stimuli (whatever comes first)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean arterial oxygen saturation | From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes | During bronchoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | During bronchoscopy | 
| Frequency of dose adjustments | From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes | During bronchoscopy | 
| Cumulative propofol dose | At time point when bronchoscope is removed (on average after 45 minutes) | At end of bronchoscopy | 
| Recovery time after bronchoscopy |  | During 2 hours after bronchoscopy |