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Fractionated Versus Target-controlled Propofol Administration in Bronchoscopy

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ClinicalTrials.gov Identifier: NCT02246023
Recruitment Status : Completed
First Posted : September 22, 2014
Last Update Posted : April 14, 2016
Sponsor:
Collaborator:
B. Braun Melsungen AG
Information provided by (Responsible Party):
Daniel Franzen, University of Zurich

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Sarcoidosis Interstitial Pneumonia Device: Flexible bronchoscopy in moderate sedation Device: Oxygen saturation Device: Blood pressure Device: Propofol dosage Device: Recovery time after bronchoscopy Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Target-controlled Versus Manually-controlled Propofol Sedation in Flexible Bronchoscopy. A Randomized Non-inferiority Trial.
Study Start Date : January 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arm Intervention/treatment
Active Comparator: 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

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

Device: Oxygen saturation
Continuous measurement of oxygen saturation;

Device: Blood pressure
Measurement of non-invasive blood pressure every 3 minutes

Device: Propofol dosage
Report of dose adjustments und cumulative propofol dosage;

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

Experimental: 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.

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

Device: Oxygen saturation
Continuous measurement of oxygen saturation;

Device: Blood pressure
Measurement of non-invasive blood pressure every 3 minutes

Device: Propofol dosage
Report of dose adjustments und cumulative propofol dosage;

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




Primary Outcome Measures :
  1. Mean arterial oxygen saturation [ Time Frame: During bronchoscopy ]
    From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes


Secondary Outcome Measures :
  1. Number of occasions with recorded an oxygen saturation of < 90% [ Time Frame: During bronchoscopy ]
    From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes

  2. Number of an oxygen desaturation of > 4% from baseline [ Time Frame: During bronchoscopy ]
    From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes

  3. Number of occasions with a systolic blood pressure < 90 mmHg during bronchoscopy, maximum oxygen requirement, [ Time Frame: During bronchoscopy ]
    From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes

  4. Frequency of dose adjustments [ Time Frame: During bronchoscopy ]
    From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes

  5. Cumulative propofol dose [ Time Frame: At end of bronchoscopy ]
    At time point when bronchoscope is removed (on average after 45 minutes)

  6. Recovery time after bronchoscopy [ Time Frame: During 2 hours after bronchoscopy ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246023


Locations
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Switzerland
University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
Daniel Franzen
B. Braun Melsungen AG
Investigators
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Principal Investigator: Daniel Franzen, MD Division of Pulmonology

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Responsible Party: Daniel Franzen, Dr. Daniel Franzen, University of Zurich
ClinicalTrials.gov Identifier: NCT02246023     History of Changes
Other Study ID Numbers: BronchoPropTCI
SNCTP000000706 ( Registry Identifier: National study registration )
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: June 2015
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases, Interstitial
Sarcoidosis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lymphoproliferative Disorders
Lymphatic Diseases
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics