Closed Loop Propofol Administration in Pediatric Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT01600287|
Recruitment Status : Completed
First Posted : May 17, 2012
Results First Posted : August 9, 2013
Last Update Posted : August 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Cardiac Surgery Intraoperative Awareness Automated Drug Delivery||Other: IAADS Other: Manual propofol administration||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Evaluation of Closed Loop Anaesthesia Delivery System for Propofol Anaesthesia in Pediatric Cardiac Surgery|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Experimental: IAADS group
dosage of propofol adjusted automatically by IAADS
In automatic mode, the system requests an update of the BIS data every 5 seconds and calculates the BIS "error" (difference between the target and actual BIS value). This value along with the trends of BIS in the epoch of the last 30 seconds as well as in the last 5 minutes is passed on to a patient individualized, model based adaptive control algorithm. The algorithm uses the error to calculate an adjustment to the propofol delivery rate, but does not apply it immediately. Adjustments to the propofol delivery rate are only made every 30 seconds, taking into account the sum of previous six BIS "error" values, the trends of BIS in the epoch of last 30 seconds as well as in the last 5 minutes, time elapsed since the initiation of infusion, pharmacokinetics, the time delay factor between sensing and averaging of BIS data, the time delay factor between the change in infusion rate and the actual change in the plasma concentration of propofol as well as the peak effect of propofol.
Active Comparator: Manual group
dosage of propofol adjusted manually
Other: Manual propofol administration
In "manual" mode, the user can also control the propofol infusion rate manually, using the keyboard or the mouse of the PC. The PC displays a graph of the propofol delivery rate and trend of BIS value.
- Percentage of Time Bispectral Index(BIS) Remains+/-10 of Target [ Time Frame: Approximately 8 hours ]The primary outcome to be measured is the ability of the system to keep the depth of anesthesia in the target range, i.e, Bispectral Index(BIS) value of 50+/- 10. This will assess the ability of the system to prevent intra-operative awareness of the patients and at the same time avoid excessive depth of anesthesia with its accompanying adverse effects.
- Median Performance Error(MDPE) [ Time Frame: Approximately 8 hours ]The difference between the observed and target of measure of depth of anesthesia (BIS) expressed as percentage of target BIS is calculated as performance error every 30 seconds. This value may be either '+' or '_' indicating whether the observed measure is above the target (overshoot-+) or below the target (undershoot-_). The median value of all performance errors during propofol anesthesia is median performance error and is a measure of bias of the system. This outcome is expressed as the mean of Median Performance Errors per participant.
- Median Absolute Performance Error(MDAPE) [ Time Frame: Approximately 8 hours ]The difference between the observed and target of measure of depth of anesthesia (BIS) expressed as percentage of target BIS is calculated as performance error every 30 seconds. This value may be either '+' or '_' indicating whether the observed measure is above the target (overshoot-+) or below the target (undershoot-_).The median of the absolute values of performance errors (without considering the direction of error) is median absolute performance error. This outcome measures the magnitude of error or inaccuracy of the system studied. A lower value indicates a more precise system.This outcome is expressed as the mean of Median Absolute Performance Errors per participant.
- Wobble [ Time Frame: Approximately 8 hours ]Wobble measures the intra-individual variability in performance error.The median of the difference between individual performance errors throughout anesthesia and the median performance error for each participant is the wobble of that participant. The mean value per participant is indicated in the outcome measure.
- Percentage of Time Heart Rate Remains Within 25% of Pre-op Baseline [ Time Frame: Approximately 8 hours ]The duration of time heart rate remains within 25% of the pre-operative baseline value during the period propofol (general anesthetic) is administered to the study population. This value is expressed as a percentage. This outcome is expressed as the mean of percentage of time per participant.
- Percentage of Time Mean Arterial Pressure Remains Within 25% of Pre-op Baseline [ Time Frame: Approximately 8 hours ]The duration of time mean arterial pressure remains within 25% of the pre-operative baseline value during the period propofol (general anesthetic) is administered to the study population. This value is expressed as percentage. This outcome is expressed as the mean of percentage of time per participant
- Intra-operative Awareness [ Time Frame: Approximately 3 days and then 1 month later ]The number of patients who will be able to recall the intra-operative events when assessed postoperatively. This will be assessed by a structured protocol
- Divergence [ Time Frame: 8 hours (approx) ]slope of the linear regression curve of performance error against time.
- Global Score [ Time Frame: 8 hours (approx) ]overall performance assessment of the system calculated as= [(MDAPE+Wobble)/percentage of time BIS remains within target]x100 Lower score indicates better overall performance
- Intraoperative Phenylephrine Used (Pre CPB) [ Time Frame: 2 hours(approx) ]total phenylephrine dose needed to be used in the pre CPB period to maintain hemodynamic stability
- Induction Dose of Propofol [ Time Frame: 10 minutes ]Dose of propofol needed for induction
- Induction Time [ Time Frame: 10 minutes ]Time required for the first time achievement of two subsequent BIS values below or equal to 55
- Minimum BIS During Induction [ Time Frame: 15 minutes ]Bispectral Index(BIS) is an EEG-based objective measure of anesthetic depth with values ranging from 100 to 0, lower number indicating greater depth of anesthesia. Values between 40 to 60 indicate adequate depth required for surgery. During induction of anesthesia, there is a tendency of overshooting the adequate depth of anesthesia, due to use of higher dose and rate of administration required for induction. The minimum BIS achieved during induction is a measure of this overshoot. The less the minimum value, the more is the overshoot, worse the outcome is. The minimum BIS during induction is automatically stored in the PC used for the study.
- Percentage Fall in MAP During Induction [ Time Frame: 15 minutes ]percentage fall in mean arterial pressure from baseline during induction
- Total Propofol Used (mg/kg/hr) [ Time Frame: 8 hours (approx) ]total propofol used based on per kg body weight per hour for the whole duration of surgery
- Total Fentanyl Used (µg/kg) [ Time Frame: 8 hours(approx) ]total fentanyl used in the whole duration of surgery on per kg body weight basis
- Total Off CPB Propofol Used (mg/kg/hr [ Time Frame: 6 hours(approx) ]total dosage of propofol used on per kg body weight per hour basis in the period before and after cardiopulmonary bypass period.
- Number of Times Rate of Propofol Changed Manually [ Time Frame: 8 hours(aprrox) ]Number of times rate of propofol needed to be changed manually
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01600287
|Advanced Cardiac Centre.Postgraduate Institute of Medical Education and Research.|
|Chandigarh, India, 160012|
|Principal Investigator:||Indranil Biswas, MBBS||Postgraduate Institute of Medical Education and Research|
|Principal Investigator:||Goverdhan D Puri, MBBS,MD,PhD||Postgraduate Institute of Medical Education and Research|
|Principal Investigator:||Preethy J Mathew, MBBS,MD||Postgraduate Institute of Medical Education and Research|