N/A
N=40
Closed Loop Isoflurane Administration With Bispectral Index in Open Heart Surgery
Open Heart Surgery
Bottom Line
View on ClinicalTrials.gov: NCT01069562 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2011
Primary outcome: Primary: Percentage of Time Bispectral Index Remains Within 10 of Target BIS of 50 — 75.9; 84.6 percentage of time
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Conventional control (Other); Closed loop control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time Bispectral Index Remains Within 10 of Target BIS of 50 |
75.9; 84.6 | — |
| SECONDARY Median Performance Error (MDPE) |
7.5; 4.8 | — |
| SECONDARY Median Absolute Performance Error (MDAPE) |
13.2; 11.0 | — |
| SECONDARY Wobble |
9.3; 8.7 | — |
| SECONDARY Percentage of Time Heart Rate Remained Within 25% of Pre-op Baseline |
77.3; 86.1 | — |
| SECONDARY Percentage of Time Mean Arterial Pressure Remained Within 25% of Pre-op Baseline |
76.0; 80.4 | — |
| SECONDARY Intra-operative Awareness |
0; 0 | — |
| SECONDARY Fentanyl Used |
10.1; 10.1 | — |
| SECONDARY Intra Operative Adrenaline Used |
2.6; 2.7 | — |
| SECONDARY INTRA OPERATIVE PHENYLEPHRINE USED |
5.2; 4.5 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01069562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.