Open Heart Surgery Clinical Trial
Official title:
Comparison of Isoflurane Anaesthesia by Closed Loop Controlled Administration Versus Manually Controlled Administration Using Bispectral Index in Open Heart Surgery
With the advancement in microprocessor technology and better understanding of
pharmacodynamics and pharmacokinetics of anaesthetic agents, computer facilitated closed
loop control of anaesthesia using propofol has been shown to be accurate with better
performance than manual control. Literature on computer controlled administration of
inhalational anaesthetics is few, as it requires the computer to control the dial setting on
the vapouriser. The investigators intend to compare the computer controlled closed loop
administration of isoflurane by infusing it into the anaesthetic circuit with conventional
vaporiser control in elective open heart surgery.
40 patients (ASA (American Society of Anesthesiology) class II-IV; 18- 65 years) undergoing
elective cardiac surgery requiring cardiopulmonary bypass (CPB) will be randomly divided
into manual or closed loop groups. Propofol will be used for induction of anaesthesia in
both groups followed by isoflurane for maintenance. In the manual group, isoflurane will be
administered through the Tech 7 vapouriser during pre and post CPB periods to target
bispectral index (BIS) of 50. In closed loop group, isoflurane will be administered using
infusion of liquid isoflurane into expiratory limb of the closed circuit. This rate of
infusion though a conventional syringe pump will be controlled by algorithm termed
'Improvised Anaesthetic Agent Delivery System' (IAADS) to maintain BIS of 50. Patients in
both groups will receive 500ml of 100 % oxygen as fresh gas flow. The % of time bispectral
index (BIS) is within the 10 of set target BIS of 50 will be the primary outcome measure.
The secondary outcome measures will be median performance error (MDPE)(2), median absolute
performance error (MDAPE)(2), wobble(2), divergence(2), amount of isoflurane used and
hemodynamic parameters will be secondary outcome measures.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - American Society of Anesthesiology physical status 2- 4 - elective open heart surgery under general anaesthesia - requiring Cardio Pulmonary Bypass (CPB) Exclusion Criteria: - body weight ±30% of the ideal body weight - neurological disorder - use of any psychoactive medication - severe stenotic valve lesions - severe pulmonary artery hypertension - Tetrology of Fallot repair and other cyanotic heart diseases. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
Country | Name | City | State |
---|---|---|---|
India | Post graduate 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
Locher S, Stadler KS, Boehlen T, Bouillon T, Leibundgut D, Schumacher PM, Wymann R, Zbinden AM. A new closed-loop control system for isoflurane using bispectral index outperforms manual control. Anesthesiology. 2004 Sep;101(3):591-602. — 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
Varvel JR, Donoho DL, Shafer SL. Measuring the predictive performance of computer-controlled infusion pumps. J Pharmacokinet Biopharm. 1992 Feb;20(1):63-94. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Time Bispectral Index Remains Within 10 of Target BIS of 50 | The duration of time depth of anesthesia was maintained in the recommended range (as measured by BIS) during the period isoflurane (general anesthetic) was administered to the study population. This value expressed as percentage is the primary outcome. BIS is an objective measure of depth of anesthesia derived from statistical(bispectral) analysis of electroencephalographic waves. BIS ranges from 0 to 100. It decreases monotonically from 100 in the awake state to lower values with sedation and anesthesia. | 8 hours (approximately) | 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 isoflurane 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. | 8 hours (approximately) | No |
Secondary | Median Absolute Performance Error (MDAPE) | 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. | 8 hours (approximately) | 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. | 8 hours (approximately) | No |
Secondary | Percentage of Time Heart Rate Remained Within 25% of Pre-op Baseline | The duration of time heart rate remained within 25% of the pre-operative baseline value during the period isoflurane (general anesthetic) was 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. | 8 hours (approximately) | Yes |
Secondary | Percentage of Time Mean Arterial Pressure Remained Within 25% of Pre-op Baseline | The duration of time mean arterial pressure remained within 25% of the pre-operative baseline value during the period isoflurane (general anesthetic) was administered to the study population. This value is expressed as percentage. This outcome is expressed as the mean of percentage of time per participant | 8 hours (approximately) | Yes |
Secondary | Intra-operative Awareness | The number of patients who were able to recall the intra-operative events when assessed postoperatively. This was assessed by a structured protocol | 3 days (approximately) | Yes |
Secondary | Fentanyl Used | The total amount of fentanyl that was used during the procedure. | 8 hours (approximately) | No |
Secondary | Intra Operative Adrenaline Used | The amount of adrenaline used during the procedure | 8 hours (approximately) | No |
Secondary | INTRA OPERATIVE PHENYLEPHRINE USED | The amount of phenylephrine used during the procedure. | 8 hours (approximately) | No |
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