Clinical trial NCT01101477: Target-Controlled Infusion of Propofol for Flexible Bronchoscopy Sedation
Official title: Target-Controlled Infusion of Propofol for Flexible Bronchoscopy Sedation: Determining the Optimal Titrating Regimen
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Flexible Bronchoscopy
Keywords: Target-controlled infusion,
bronchoscopy,
sedation,
propofol
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2010-04-12
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Number of Patients With Hypoxemia During Flexible Bronchoscopy
timeFrame: During sedative induction and bronchoscopy
measure: The Number of Changes in Target Effect Site Concentration During Flexible Bronchoscopy
timeFrame: During sedative induction and bronchoscopy
Secondary outcomes:
measure: The Recovery Time to Orientation
timeFrame: after bronchosocpy
measure: The Total Doses of Propofol During Induction and Overall Procedures
timeFrame: after bronchoscopy
measure: The Cooperation of Patients From the View of Bronchoscopists
timeFrame: After bronchoscopy
measure: The Global Tolerance for Flexible Bronchoscopy
timeFrame: After recovery
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Department of Thoracic Medicine, Chang Gung Memorial Hospital
Study officials:
affiliation: Department of Thoracic Medicine, Chang Gung Memorial hospital
name: Ting-Yu Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.