Fractionated Versus Target-controlled Propofol Administration in Bronchoscopy

Daniel Franzen

Status and phase: Completed; Phase 4

Conditions: Sarcoidosis; Interstitial Pneumonia; Lung Cancer

Treatments: Device: Oxygen saturation; Device: Flexible bronchoscopy in moderate sedation; Device: Recovery time after bronchoscopy; Device: Propofol dosage; Device: Blood pressure

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02246023

BronchoPropTCI

SNCTP000000706 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 2 patient groups

Fractionated propofol administration

Active Comparator group

Description:

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

Treatment:

Device: Recovery time after bronchoscopy

Device: Oxygen saturation

Device: Propofol dosage

Device: Blood pressure

Device: Flexible bronchoscopy in moderate sedation

Propofol-TCI

Experimental group

Description:

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.

Treatment:

Device: Recovery time after bronchoscopy

Device: Oxygen saturation

Device: Propofol dosage

Device: Blood pressure

Device: Flexible bronchoscopy in moderate sedation