Intraoperative Awareness Clinical Trial
Official title:
Evaluation of Closed Loop Anaesthesia Delivery System for Propofol Anaesthesia in Pediatric Cardiac Surgery
The purpose of the study is to evaluate and compare the feasibility, efficacy and safety of IAADS (Improved Anaesthetic Agent Delivery System) for propofol anaesthesia against manual control using bispectral index in paediatric patients undergoing open heart surgery under cardio-pulmonary bypass.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 5 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Children, aged 5-18 years and ASA (American Society of Anesthesiology) physical status 2-3, planned for elective open heart surgery under general anaesthesia. Exclusion Criteria: - Patients weighing more than ±30% of ideal body weight. - Patients having neurological/psychological disorders or on psychoactive medications. - Patients belonging to NYHA (New York Heart Association) class IV. - Patients with severe stenotic valvular lesions, eg, mitral or aortic stenosis. - Patients with known allergy to propofol or any of its constituents. - Patients having severe pulmonary arterial hypertension. - Patients with cyanotic congenital heart disease. - Patients requiring deep hypothermic circulatory arrest during surgery. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
Country | Name | City | State |
---|---|---|---|
India | Advanced Cardiac Centre.Postgraduate Institute of Medical Education and Research. | Chandigarh |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Medical Education and Research |
India,
Agarwal J, Puri GD, Mathew PJ. Comparison of closed loop vs. manual administration of propofol using the Bispectral index in cardiac surgery. Acta Anaesthesiol Scand. 2009 Mar;53(3):390-7. doi: 10.1111/j.1399-6576.2008.01884.x. — View Citation
Puri GD, Kumar B, Aveek J. Closed-loop anaesthesia delivery system (CLADS) using bispectral index: a performance assessment study. Anaesth Intensive Care. 2007 Jun;35(3):357-62. — View Citation
Solanki A, Puri GD, Mathew PJ. Bispectral index-controlled postoperative sedation in cardiac surgery patients: a comparative trial between closed loop and manual administration of propofol. Eur J Anaesthesiol. 2010 Aug;27(8):708-13. doi: 10.1097/EJA.0b013e328335b2d4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Induction Dose of Propofol | Dose of propofol needed for induction | 10 minutes | No |
Other | Induction Time | Time required for the first time achievement of two subsequent BIS values below or equal to 55 | 10 minutes | No |
Other | Minimum BIS During Induction | 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. | 15 minutes | No |
Other | Percentage Fall in MAP During Induction | percentage fall in mean arterial pressure from baseline during induction | 15 minutes | Yes |
Other | Total Propofol Used (mg/kg/hr) | total propofol used based on per kg body weight per hour for the whole duration of surgery | 8 hours (approx) | No |
Other | Total Fentanyl Used (µg/kg) | total fentanyl used in the whole duration of surgery on per kg body weight basis | 8 hours(approx) | No |
Other | Total Off CPB Propofol Used (mg/kg/hr | total dosage of propofol used on per kg body weight per hour basis in the period before and after cardiopulmonary bypass period. | 6 hours(approx) | No |
Other | Number of Times Rate of Propofol Changed Manually | Number of times rate of propofol needed to be changed manually | 8 hours(aprrox) | No |
Primary | Percentage of Time Bispectral Index(BIS) Remains+/-10 of Target | 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. | Approximately 8 hours | No |
Secondary | Median Performance Error(MDPE) | 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. | Approximately 8 hours | No |
Secondary | Median Absolute Performance Error(MDAPE) | 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. | Approximately 8 hours | No |
Secondary | Wobble | 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. | Approximately 8 hours | No |
Secondary | Percentage of Time Heart Rate Remains Within 25% of Pre-op Baseline | 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. | Approximately 8 hours | Yes |
Secondary | Percentage of Time Mean Arterial Pressure Remains Within 25% of Pre-op Baseline | 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 | Approximately 8 hours | Yes |
Secondary | Intra-operative Awareness | 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 | Approximately 3 days and then 1 month later | Yes |
Secondary | Divergence | slope of the linear regression curve of performance error against time. | 8 hours (approx) | No |
Secondary | Global Score | overall performance assessment of the system calculated as= [(MDAPE+Wobble)/percentage of time BIS remains within target]x100 Lower score indicates better overall performance | 8 hours (approx) | No |
Secondary | Intraoperative Phenylephrine Used (Pre CPB) | total phenylephrine dose needed to be used in the pre CPB period to maintain hemodynamic stability | 2 hours(approx) | No |
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