Target-Controlled Infusion of Propofol for Flexible Bronchoscopy Sedation

Not Applicable

Terminated

Conditions: Flexible Bronchoscopy

Interventions: Procedure: TCI titration by different Cet.

Registration Number: NCT01101477

Lead Sponsor: Chang Gung Memorial Hospital

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 144

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Titration by target effect site concentration (Cet) 0.5μg/ml	TCI titration by different Cet.	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.
Titration by Cet 0.2μg/ml	TCI titration by different Cet.	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.
Titration by Cet 0.1μg/ml	TCI titration by different Cet.	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.

Primary Outcome Measures

Name	Time	Method
The Number of Patients With Hypoxemia During Flexible Bronchoscopy	During sedative induction and bronchoscopy	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	During sedative induction and 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.

Secondary Outcome Measures

Name	Time	Method
The Recovery Time to Orientation	after bronchosocpy	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	after bronchoscopy	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	After bronchoscopy	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	After recovery	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)