Target-Controlled Infusion of Propofol for Flexible Bronchoscopy Sedation

NCT ID: NCT01101477

Last Updated: 2011-12-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-08-31

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.

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.

Conditions

Flexible Bronchoscopy

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

TCI titration by different Cet.

Intervention Type: 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 0.2μg/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.

Group Type: ACTIVE_COMPARATOR

TCI titration by different Cet.

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

TCI titration by different Cet.

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

林定佑

Attending physician, Lecture of Medicine, Division of Thoracic Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ting-Yu Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Thoracic Medicine, Chang Gung Memorial hospital

Locations

Department of Thoracic Medicine, Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 17049322 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23638141 (View on PubMed)

Other Identifiers

98-3441A3

Identifier Type: -

Identifier Source: org_study_id