Target-Controlled Infusion of Propofol for Flexible Bronchoscopy Sedation

This study has been terminated.
(Hypoxemia(SPaO2<80%) episodes occured significantly in the arm titration by 0.5ug/ml)
Sponsor:
Information provided by (Responsible Party):
林定佑, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01101477
First received: April 7, 2010
Last updated: November 5, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Flexible Bronchoscopy
Procedure: TCI titration by different Cet.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Target-Controlled Infusion of Propofol for Flexible Bronchoscopy Sedation: Determining the Optimal Titrating Regimen

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • The Number of Patients With Hypoxemia During Flexible Bronchoscopy [ Time Frame: During sedative induction and bronchoscopy ] [ Designated as safety issue: Yes ]

    Hypoxemia is defined as:

    Oxyhemoglobin saturation (SPO2) is less than 90 % with any duration


  • The Number of Changes in Target Effect Site Concentration During Flexible Bronchoscopy [ Time Frame: During sedative induction and bronchoscopy ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The Recovery Time to Orientation [ Time Frame: after bronchosocpy ] [ Designated as safety issue: No ]
    The recovery time to orientation was defined as the time between finishing bronchoscopy to the time when the patients could spontaneously open their eyes, recall their date of birth, and correctly perform finger-nose test.

  • The Total Doses of Propofol During Induction and Overall Procedures [ Time Frame: after bronchoscopy ] [ Designated as safety issue: No ]
    The dosses of propofol used during induction and overall flexible bronchoscopy will be recored from the screen of the TCI pump.

  • The Cooperation of Patients From the View of Bronchoscopists [ Time Frame: After bronchoscopy ] [ Designated as safety issue: No ]
    After the bronchoscopy, the bronchoscopist will be asked by 10-point Verbal Analogus Scale (0: the best cooperation, 10: the worst cooperation) to express how they fell about the cooperation of patients undergoing the bronchoscopy.

  • The Global Tolerance for Flexible Bronchoscopy [ Time Frame: After recovery ] [ Designated as safety issue: No ]
    After the recovery, patients will be asked about the tolerance of bronchoscopy performed to them by 10-point Verbal Analogus Scale (0: best tolerance, 10: worst tolerance)


Enrollment: 144
Study Start Date: February 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Titration by target effect site concentration (Cet) 0.5μg/ml
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.

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.

Active Comparator: Titration by Cet 0.2μg/ml
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.

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.

Active Comparator: Titration by Cet 0.1μg/ml
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.

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.


Detailed Description:

Propofol is ideal for bronchoscopy sedation because of its fast onset and quick recovery effect. Our research and reports from different investigators demonstrate that patients received propofol sedation recover fast with excellent satisfaction for bronchoscopy. However, the amount of propofol for induction and maintenance is calculated simply by patient's body weight and physicians' experience. For those non-anesthesiologists, who perform sedative work outside the operating room, and inexperienced anesthesiologist without fully considering the individual pharmacokinetic and pharmacodynamic differences may generate unstable drug plasma concentration and increase cardio-respiration suppression. Therefore, a manner which can assess and measure objectively individual pharmacokinetic differences may improve the sedative quality and decrease the complication rate.

A model called "Target-controlled infusion"(TCI), built from massive pharmacokinetic samples of propofol, could now give precise pharmacokinetic control. Several pharmacokinetic models built-in in TCI, includes the Schnider model which use concentration of effect site (Ce, the propofol concentration in the brain) as the sedative guide. The model integrates individual variants of age, height, weight and gender to calculate the infusion profile to achieve predetermined steady "target effect site concentration" (Cet). Because of the unique consideration of individual pharmacokinetic variants and Ce targeting, TCI provides predictable sedative level and is suitable for procedures requiring narrowing therapeutic level. Beside general anesthesia, TCI has been applied in breast biopsy, upper gastrointestinal endoscopic ultrasound and endoscopic retrograde cholangiopancreatography at outpatient clinic. According to these evidences, there is potential role of TCI in bronchoscopic sedation.

Based on current evidence and our experience, we design this study to evaluate the optimal regimen for induction and procedure during bronchoscopy. We hope this study could provide the more safety and efficient bronchoscopic sedation for patients and physicians.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101477

Locations
Taiwan
Department of Thoracic Medicine, Chang Gung Memorial Hospital
Taoyuan, Taiwan, 33305
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Ting-Yu Lin, MD Department of Thoracic Medicine, Chang Gung Memorial hospital
  More Information

Publications:
Responsible Party: 林定佑, Attending physician, Lecture of Medicine, Division of Thoracic Medicine, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01101477     History of Changes
Other Study ID Numbers: 98-3441A3
Study First Received: April 7, 2010
Results First Received: November 5, 2011
Last Updated: November 5, 2011
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Target-controlled infusion,
bronchoscopy,
sedation,
propofol

Additional relevant MeSH terms:
Propofol
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on July 22, 2014