University Hospital Zurich
Zurich, Canton of Zurich, 8091, Switzerland
NCT Number: NCT02246023
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.
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Notify Me18 year–85 year
All sexes
Interventional
Phase 4
Zurich, Canton of Zurich, 8091, Switzerland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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)
Time frame: During bronchoscopy
From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
Time frame: During bronchoscopy
From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
Time frame: During bronchoscopy
From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
Time frame: During bronchoscopy
From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
Time frame: During bronchoscopy
From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
Time frame: At end of bronchoscopy
At time point when bronchoscope is removed (on average after 45 minutes)
Time frame: During 2 hours after bronchoscopy
Daniel Franzen
Other
Target-controlled Versus Manually-controlled Propofol Sedation in Flexible Bronchoscopy. A Randomized Non-inferiority Trial.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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