Fractionated Versus Target-controlled Propofol Administration in Bronchoscopy

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02246023
• Other study ID #: BronchoPropTCI
• Secondary ID: SNCTP000000706
• Status: Completed
• Phase: Phase 4
• First received: September 15, 2014
• Last updated: April 13, 2016
• Start date: January 2015
• Est. completion date: February 2016

Study information

• Verified date: June 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Interstitial Pneumonia
• Lung Cancer
• Lung Diseases, Interstitial
• Sarcoidosis

Intervention

Device:
• Flexible bronchoscopy in moderate sedation
Flexible bronchoscopy for diagnosis of lung cancer, sarcoidosis or interstitial pneumonia in moderate sedation with propofol;
• Oxygen saturation
Continuous measurement of oxygen saturation;
• Blood pressure
Measurement of non-invasive blood pressure every 3 minutes
• Propofol dosage
Report of dose adjustments und cumulative propofol dosage;
• Recovery time after bronchoscopy
Recovery time after bronchoscopy from removal of bronchoscope to eye opening/answer to verbal stimuli (whatever comes first)

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Daniel Franzen	B. Braun Melsungen AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean arterial oxygen saturation	From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes	During bronchoscopy	Yes
Secondary	Number of occasions with recorded an oxygen saturation of < 90%	From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes	During bronchoscopy	Yes
Secondary	Number of an oxygen desaturation of > 4% from baseline	From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes	During bronchoscopy	Yes
Secondary	Number of occasions with a systolic blood pressure < 90 mmHg during bronchoscopy, maximum oxygen requirement,	From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes	During bronchoscopy	Yes
Secondary	Frequency of dose adjustments	From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes	During bronchoscopy	No
Secondary	Cumulative propofol dose	At time point when bronchoscope is removed (on average after 45 minutes)	At end of bronchoscopy	No
Secondary	Recovery time after bronchoscopy		During 2 hours after bronchoscopy	No