Fractionated Versus Target-controlled Propofol Administration in Bronchoscopy

Phase 4

Completed

• Conditions: Interstitial Pneumonia; Lung Cancer; Sarcoidosis
• Interventions: Device: Flexible bronchoscopy in moderate sedation; Device: Oxygen saturation; Device: Blood pressure; Device: Propofol dosage; Device: Recovery time after bronchoscopy

• Registration Number: NCT02246023
• Lead Sponsor: Daniel Franzen

Brief Summary

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

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 Timeline

• Study First Submitted: 2014-09-15
• Study First Submitted QC: 2014-09-19
• Study First Posted: 2014-09-22
• Study Start: 2015-01
• Status Verified: 2015-06
• Primary Completion: 2015-12
• Study Completion: 2016-02
• Last Update Submitted: 2016-04-13
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol-TCI	Recovery time after bronchoscopy	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.
Fractionated propofol administration	Flexible bronchoscopy in moderate sedation	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
Fractionated propofol administration	Oxygen saturation	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
Propofol-TCI	Oxygen saturation	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.
Fractionated propofol administration	Blood pressure	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
Fractionated propofol administration	Recovery time after bronchoscopy	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
Propofol-TCI	Propofol dosage	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.
Propofol-TCI	Blood pressure	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.
Fractionated propofol administration	Propofol dosage	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
Propofol-TCI	Flexible bronchoscopy in moderate sedation	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.

Primary Outcome Measures

Name	Time	Method
Mean arterial oxygen saturation	During bronchoscopy	From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes

Secondary Outcome Measures

Name	Time	Method
Number of occasions with recorded an oxygen saturation of < 90%	During bronchoscopy	From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
Number of an oxygen desaturation of > 4% from baseline	During bronchoscopy	From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
Number of occasions with a systolic blood pressure < 90 mmHg during bronchoscopy, maximum oxygen requirement,	During bronchoscopy	From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
Frequency of dose adjustments	During bronchoscopy	From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
Cumulative propofol dose	At end of bronchoscopy	At time point when bronchoscope is removed (on average after 45 minutes)
Recovery time after bronchoscopy	During 2 hours after bronchoscopy

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zurich, Switzerland