NCT02246023

Fractionated Versus Target-controlled Propofol Administration in Bronchoscopy

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Daniel Franzen · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-12-01
• Completion: 2016-02-01
• First posted: 2014-09-22
• Last updated: 2016-04-14

Locations

1 site across 1 country: Switzerland