Fractionated Versus Target-controlled Propofol Administration in Bronchoscopy

April 13, 2016 updated by: Daniel Franzen

Target-controlled Versus Manually-controlled Propofol Sedation in Flexible Bronchoscopy. A Randomized Non-inferiority Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean arterial oxygen saturation
Time Frame: During bronchoscopy
From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
During bronchoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During bronchoscopy
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
During bronchoscopy
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
During bronchoscopy
Frequency of dose adjustments
Time Frame: During bronchoscopy
From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
During bronchoscopy
Cumulative propofol dose
Time Frame: At end of bronchoscopy
At time point when bronchoscope is removed (on average after 45 minutes)
At end of bronchoscopy
Recovery time after bronchoscopy
Time Frame: During 2 hours after bronchoscopy
During 2 hours after bronchoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daniel Franzen

Collaborators

B. Braun Melsungen AG

Investigators

  • Principal Investigator: Daniel Franzen, MD, Division of Pulmonology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

September 15, 2014

First Submitted That Met QC Criteria

September 19, 2014

First Posted (Estimate)

September 22, 2014

Study Record Updates

Last Update Posted (Estimate)

April 14, 2016

Last Update Submitted That Met QC Criteria

April 13, 2016

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BronchoPropTCI
  • SNCTP000000706 (Registry Identifier: National study registration)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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