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Hypoxemia(SPaO2<80%) episodes occured significantly in the arm titration by 0.5ug/ml
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Titration by target effect site concentration (Cet) 0.5μg/ml | Active Comparator | 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 | Active Comparator | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCI titration by different Cet. | 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:
The Cet will be decreased if:
with any duration. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Patients With Hypoxemia During Flexible Bronchoscopy | Hypoxemia is defined as: Oxyhemoglobin saturation (SPO2) is less than 90 % with any duration | 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. | During sedative induction and bronchoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | after bronchosocpy |
| The Total Doses of Propofol During Induction and Overall Procedures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ting-Yu Lin, MD | Department of Thoracic Medicine, Chang Gung Memorial hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Thoracic Medicine, Chang Gung Memorial Hospital | Taoyuan | 33305 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17049322 | Background | 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. | |
| 23638141 |
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If patients or accompanying family refused to paticipate anytime before assignment to groups.
Patients undergoing elective flexible bronchoscopy (FB) and sedation were screened for enrolment at the bronchoscopic room on the day of exam.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Titration by Cet 0.2μg/ml |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Patients With Hypoxemia During Flexible Bronchoscopy | Hypoxemia is defined as: Oxyhemoglobin saturation (SPO2) is less than 90 % with any duration | The participants who received intervention completely were analyzed. | Posted | Number | participants | During sedative induction and bronchoscopy |
|
From the starting of induction to patients leaving the bronchoscopic room after recovery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| oxyhemoglobin saturation (SpO2) less than 80% | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
Early termination leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ting-Yu Lin | Chang Gung Memorial Hospital | 886 3 3281200 | 5108 | yuebaoyuebao@yahoo.com.tw |
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The dosses of propofol used during induction and overall flexible bronchoscopy will be recored from the screen of the TCI pump. |
| 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. | 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) | After recovery |
| Derived |
| 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. |
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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 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. |
|
|
|
| Primary | 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. | Not Posted | During sedative induction and bronchoscopy |
| Secondary | 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. | Not Posted | after bronchosocpy |
| Secondary | 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. | Not Posted | after bronchoscopy |
| Secondary | 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. | Not Posted | After bronchoscopy |
| Secondary | 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) | Not Posted | After recovery |
| 0 |
| 44 |
| 6 |
| 44 |
| EG001 | 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. | 0 | 46 | 1 | 46 |
| EG002 | 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. | 0 | 45 | 2 | 45 |
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