Target-Controlled Infusion of Propofol for Flexible Bronchoscopy Sedation

NCT01101477 | Terminated Results

• 1 other identifier: 98-3441A3
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Target-controlled infusion,; bronchoscopy,; sedation,; propofol

Outcome Measures

Primary Outcomes (2)

• The Number of Patients With Hypoxemia During Flexible Bronchoscopy

  Hypoxemia is defined as: Oxyhemoglobin saturation (SPO2) is less than 90 % with any duration

  During sedative induction and bronchoscopy

• The Number of Changes in Target Effect Site Concentration During Flexible Bronchoscopy

  The investigator will titrate the target effect site concentration (Cet) during bronchoscopy according to protocol to keep stable vital signs and sedative levels. The numbers of adjustment will be recorded to show which regimen required less adjustment to keep stable sedative levels and vital signs.

  During sedative induction and bronchoscopy

Secondary Outcomes (4)

• The Recovery Time to Orientation

  after bronchosocpy

• The Total Doses of Propofol During Induction and Overall Procedures

  after bronchoscopy

• The Cooperation of Patients From the View of Bronchoscopists

  After bronchoscopy

• The Global Tolerance for Flexible Bronchoscopy

  After recovery

Study Arms (3)

Titration by target effect site concentration (Cet) 0.5μg/ml

ACTIVE COMPARATOR

The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.

Procedure: TCI titration by different Cet.

Titration by Cet 0.2μg/ml

ACTIVE COMPARATOR

The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.

Procedure: TCI titration by different Cet.

Titration by Cet 0.1μg/ml

ACTIVE COMPARATOR

The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.

Procedure: TCI titration by different Cet.

Interventions

TCI titration by different Cet. PROCEDURE

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.

Titration by Cet 0.1μg/ml; Titration by Cet 0.2μg/ml; Titration by target effect site concentration (Cet) 0.5μg/ml

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18 years old or more) required elective flexible bronchoscopy and sedation.

You may not qualify if:

• American Society of Anesthesiologists classification of physical status 4 and 5, including hepatic or renal failure, severe obstructive sleep apnea and severe chronic obstructive pulmonary disease.
• Mallampati score 4 or 5.
• Significant Central nervous system disorders or other factors contributing to access consciousness difficultly.
• Men with body mass index(BMI) large than 42，Females with BMI large than 35.
• Allergic history to study drugs.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Department of Thoracic Medicine, Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

Related Publications (2)

• Fanti L, Agostoni M, Arcidiacono PG, Albertin A, Strini G, Carrara S, Guslandi M, Torri G, Testoni PA. Target-controlled infusion during monitored anesthesia care in patients undergoing EUS: propofol alone versus midazolam plus propofol. A prospective double-blind randomised controlled trial. Dig Liver Dis. 2007 Jan;39(1):81-6. doi: 10.1016/j.dld.2006.09.004. Epub 2006 Oct 16.

  PMID: 17049322 BACKGROUND

• Lin TY, Lo YL, Hsieh CH, Ni YL, Wang TY, Lin HC, Wang CH, Yu CT, Kuo HP. The potential regimen of target-controlled infusion of propofol in flexible bronchoscopy sedation: a randomized controlled trial. PLoS One. 2013 Apr 24;8(4):e62744. doi: 10.1371/journal.pone.0062744. Print 2013.

  PMID: 23638141 DERIVED

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Dr. Ting-Yu Lin
• Organization: Chang Gung Memorial Hospital

yuebaoyuebao@yahoo.com.tw

886 3 3281200

Study Officials

• Ting-Yu Lin, MD

  Department of Thoracic Medicine, Chang Gung Memorial hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician, Lecture of Medicine, Division of Thoracic Medicine

Study Record Dates

• First Submitted: April 7, 2010
• First Posted: April 12, 2010
• Study Start: February 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: December 8, 2011
• Results First Posted: December 8, 2011

Record last verified: 2011-11

Locations

TW (1)