An interventional study of TCI titration by different Cet. in Flexible Bronchoscopy, sponsored by Chang Gung Memorial Hospital. Terminated at 1 site in Taiwan. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2011-12-08.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment
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.
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.
Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
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.
The Number of Patients With Hypoxemia During Flexible Bronchoscopy
Hypoxemia is defined as: Oxyhemoglobin saturation (SPO2) is less than 90 % with any duration
Time frame: 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.
Time frame: During sedative induction and bronchoscopy
The Recovery Time to Orientation
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.
Time frame: after bronchosocpy
The Total Doses of Propofol During Induction and Overall Procedures
The dosses of propofol used during induction and overall flexible bronchoscopy will be recored from the screen of the TCI pump.
Time frame: after bronchoscopy
The Cooperation of Patients From the View of Bronchoscopists
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.
Time frame: After bronchoscopy
The Global Tolerance for Flexible Bronchoscopy
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)
Time frame: After recovery
Patients undergoing elective flexible bronchoscopy (FB) and sedation were screened for enrolment at the bronchoscopic room on the day of exam.
| Milestone | Titration by Target Effect Site Concentration (Cet) 0.5μg/ml | Titration by Cet 0.2μg/ml | Titration by Cet 0.1μg/ml |
|---|---|---|---|
| Started | 49 | 49 | 46 |
| Completed | 44 | 46 | 45 |
| Not completed | 5 | 3 | 1 |
| Withdrew: Protocol violation | 5 | 3 | 1 |
Hypoxemia is defined as: Oxyhemoglobin saturation (SPO2) is less than 90 % with any duration
| participants | Titration by Target Effect Site Concentration (Cet) 0.5μg/ml | Titration by Cet 0.2μg/ml | Titration by Cet 0.1μg/ml |
|---|---|---|---|
| The Number of Patients With Hypoxemia During Flexible Bronchoscopy | 29 | 22 | 18 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
The dosses of propofol used during induction and overall flexible bronchoscopy will be recored from the screen of the TCI pump.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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)
Results for this outcome have not been posted.
Collected over From the starting of induction to patients leaving the bronchoscopic room after recovery.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Titration by Target Effect Site Concentration (Cet) 0.5μg/ml | — | 0/44 (0%) | 6/44 (13.6%) |
| Titration by Cet 0.2μg/ml | — | 0/46 (0%) | 1/46 (2.2%) |
| Titration by Cet 0.1μg/ml | — | 0/45 (0%) | 2/45 (4.4%) |
| Event | Titration by Target Effect Site Concentration (Cet) 0.5μg/ml | Titration by Cet 0.2μg/ml | Titration by Cet 0.1μg/ml |
|---|---|---|---|
| oxyhemoglobin saturation (SpO2) less than 80%Respiratory, thoracic and mediastinal disorders | 6/44 | 1/46 | 2/45 |
| Age, Categorical(Participants) | Titration by Target Effect Site Concentration (Cet) 0.5μg/ml | Titration by Cet 0.2μg/ml | Titration by Cet 0.1μg/ml | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 27 | 28 | 21 | 76 |
| >=65 years | 22 | 21 | 25 | 68 |
| Age Continuous(years) | Titration by Target Effect Site Concentration (Cet) 0.5μg/ml | Titration by Cet 0.2μg/ml | Titration by Cet 0.1μg/ml | Total |
|---|---|---|---|---|
| Mean | 61.4 ± 13.0 | 62.6 ± 13.5 | 63.4 ± 14.4 | 62.4 ± 13.6 |
| Sex: Female, Male(Participants) | Titration by Target Effect Site Concentration (Cet) 0.5μg/ml | Titration by Cet 0.2μg/ml | Titration by Cet 0.1μg/ml | Total |
|---|---|---|---|---|
| Female | 23 | 22 | 22 | 67 |
| Male | 26 | 27 | 24 | 77 |
| Region of Enrollment(participants) | Titration by Target Effect Site Concentration (Cet) 0.5μg/ml | Titration by Cet 0.2μg/ml | Titration by Cet 0.1μg/ml | Total |
|---|---|---|---|---|
| Taiwan | 49 | 49 | 46 | 144 |
This study is terminated, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital