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Target-Controlled Infusion of Propofol for Flexible Bronchoscopy Sedation

NCT01101477 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2011-12-08

Study results available
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Summary

Flexible bronchoscopy (FB) sedation requires keeping sedative level in a narrow window to prevent over or under sedation. Sedative drug titration according to subjective adjustment by individual physician may cause unsteady drug concentration. Target controlled infusion (TCI) has been provided a precise pharmacokinetic control of propofol, direct control the effect side, (eg. Brain) concentration (Ce), and been applied in surgical anesthesia and variable procedure sedation. We designed this pilot study to evaluate the optimal regimen of TCI in FB sedation.

Conditions

  • Flexible Bronchoscopy

Interventions

PROCEDURE

TCI titration by different Cet.

Induction: After topical xylocaine and alfentanil 5μg/kg iv 1 minute before, Cet 2.0μg/ml is started on the TCI pump ('Vial" Injectomat TIVA Agilia syringe infusion pump, Fresenius Kabi, France). The sedative level will be accessed by sedation scale "OAA/S" every 30 seconds till OAA/S ≦3(Responds only to name called loudly). The current Ce will be set as the maintenance Cet. If desired OAA/S is not achieved after reaching 2.0μg/ml,Cet will be increased every 90 seconds by the regimens be assigned until OAA/S ≦3. The current Ce will be set as the maintenance Cet. Maintenance: The Cet will be increased according to the assigned regimens if: 1. Patients become irritant and interfere procedures. 2. Patients open eyes or talk to express uncomfortable. The Cet will be decreased if: 1. Systolic blood pressure is less than 90mmHg; 2. Mean arterial blood pressure is less than 65mmHg; 3. Oxyhemoglobin saturation is less than 90 % with any duration.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Ting-Yu Lin, MD · Department of Thoracic Medicine, Chang Gung Memorial hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01101477 on ClinicalTrials.gov