Anesthetic Depth Control Using CLADS vs. TCI in Patients With LVSDF

Summary

Advancement in techniques for anaesthetic drug delivery and real time monitoring has facilitated safe induction and maintenance of anaesthesia in severely compromised patients. Cardiac diseases are the commonest causes of morbidity and left ventricular failure is the commonest clinical presentation at the end stage. LV systolic dysfunction is defined as reduction in LVEF ≤55%. Patients with LVEF 55%-46% have mild, 45%-36% moderate and ≤35% severe LV systolic dysfunction. Patients with heart failure have a diminished cardiac reserve capacity that may be further compromised by anaesthesia. In addition to depression of sympathetic activity, most anaesthetics interfere with cardiovascular performance, either by a direct myocardial depression or by modifying cardiovascular control mechanisms. Propofol with fentanyl is advocated as the best anaesthetic combination for induction of anaesthesia in patients undergoing CABG. Propofol is a drug with narrow therapeutic index and may cause severe hypotension and hemodynamic instability during induction of anaesthesia, especially if it is given in too large doses.

Automated drug delivery systems are popular for delivery of propofol. They can be of two types, depending on whether they are based on pharmacokinetic or pharmacodynamic principles. Closed Loop Anaesthesia Delivery system has been used world-wide and in our institute in patients of various age groups and in patients undergoing cardiac surgery. But still the studies are lacking in patients with moderate to severe left ventricular systolic dysfunction. Moreover none of the studies have compared the efficacy of anaesthetic drug delivery using these two devices in this group of patients.

Thus there is paucity of literature regarding PK and PD of propofol in patients with cardiac failure. The investigators hypothesized that as the Closed Loop Anaesthesia Delivery System is based on pharmacodyanamic principles, it should perform better than the Target Control Infusion system, which works on pharmacokinetic principles. The investigators planned to conduct this study to determine the anaesthetic depth control using Closed Loop Anaesthesia Delivery system vs. manual control using Target Controlled Infusion in patients with moderate to severe left ventricular systolic dysfunction.

Conditions

• Anesthesia

Interventions

DEVICE

Target Controlled Infusion

Used to control intravenous propofol delivery with target plasma concentratioins changed manually

DEVICE

Closed Loop Anesthesia Delivery System

Used to deliver propofol automatically titrated to achieve a target BIS 50, and maintain it between 40 and 60.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh

  lead OTHER

Principal Investigators

• Varun Mahajan, MBBS · Post Graduate Institute of Medical Education and Research, Chandigarh

• Tanvir Samra, MD · Post Graduate Institute of Medical Education and Research, Chandigarh

• Goverdhan D Puri, MD, PhD · Post Graduate Institute of Medical Education and Research, Chandigarh

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-07-31

Primary Completion

2015-11-30

Completion

2015-11-30