Skip to main content
OpenTrials
Completed

NCT Number: NCT02246023

Fractionated Versus Target-controlled Propofol Administration in Bronchoscopy

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flexible bronchoscopy in moderate sedation

Device

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

Oxygen saturation

Device

Continuous measurement of oxygen saturation;

Blood pressure

Device

Measurement of non-invasive blood pressure every 3 minutes

Propofol dosage

Device

Report of dose adjustments und cumulative propofol dosage;

Recovery time after bronchoscopy

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Daniel Franzen

Other

Collaborators

  • B. Braun Melsungen AG

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Sep 22, 2014
Registry last updated
Apr 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.