Fractionated Versus Target-controlled Propofol Administration in Bronchoscopy

NCT ID: NCT02246023

Last Updated: 2016-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-02-29

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.

Conditions

Lung Cancer; Sarcoidosis; Interstitial Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fractionated propofol administration

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

Group Type: ACTIVE_COMPARATOR

Flexible bronchoscopy in moderate sedation

Intervention Type: DEVICE

Flexible bronchoscopy for diagnosis of lung cancer, sarcoidosis or interstitial pneumonia in moderate sedation with propofol;

Oxygen saturation

Intervention Type: DEVICE

Continuous measurement of oxygen saturation;

Blood pressure

Intervention Type: DEVICE

Measurement of non-invasive blood pressure every 3 minutes

Propofol dosage

Intervention Type: DEVICE

Report of dose adjustments und cumulative propofol dosage;

Recovery time after bronchoscopy

Intervention Type: DEVICE

Recovery time after bronchoscopy from removal of bronchoscope to eye opening/answer to verbal stimuli (whatever comes first)

Propofol-TCI

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.

Group Type: EXPERIMENTAL

Flexible bronchoscopy in moderate sedation

Intervention Type: DEVICE

Flexible bronchoscopy for diagnosis of lung cancer, sarcoidosis or interstitial pneumonia in moderate sedation with propofol;

Oxygen saturation

Intervention Type: DEVICE

Continuous measurement of oxygen saturation;

Blood pressure

Intervention Type: DEVICE

Measurement of non-invasive blood pressure every 3 minutes

Propofol dosage

Intervention Type: DEVICE

Report of dose adjustments und cumulative propofol dosage;

Recovery time after bronchoscopy

Intervention Type: DEVICE

Recovery time after bronchoscopy from removal of bronchoscope to eye opening/answer to verbal stimuli (whatever comes first)

Interventions

Flexible bronchoscopy in moderate sedation

Flexible bronchoscopy for diagnosis of lung cancer, sarcoidosis or interstitial pneumonia in moderate sedation with propofol;

Intervention Type: DEVICE

Oxygen saturation

Continuous measurement of oxygen saturation;

Intervention Type: DEVICE

Blood pressure

Measurement of non-invasive blood pressure every 3 minutes

Intervention Type: DEVICE

Propofol dosage

Report of dose adjustments und cumulative propofol dosage;

Intervention Type: DEVICE

Recovery time after bronchoscopy

Recovery time after bronchoscopy from removal of bronchoscope to eye opening/answer to verbal stimuli (whatever comes first)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B. Braun Melsungen AG

INDUSTRY

Sponsor Role: collaborator

Daniel Franzen

OTHER

Sponsor Role: lead

Responsible Party

Daniel Franzen

Dr. Daniel Franzen

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Daniel Franzen, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Pulmonology

Locations

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

SNCTP000000706

Identifier Type: REGISTRY

Identifier Source: secondary_id

BronchoPropTCI

Identifier Type: -

Identifier Source: org_study_id