Mode
Text Size
Log in / Sign up
N/A N=40 Randomized Single-blind

Closed Loop Isoflurane Administration With Bispectral Index in Open Heart Surgery

Open Heart Surgery

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

Back to search