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

NCT02645994 | Completed

• 1 other identifier: NK/1723/MD/11719-20
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Closed Loop Anesthesia Delivery System; Target Controlled Infusion

Outcome Measures

Primary Outcomes (5)

• 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 propofol was administered to the study population. This value expressed as percentage. 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.

  approx 8 hours

• 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

  approx 8 hrs

• 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.

  approx 8 hrs

• 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.

  approx 8 hrs

• Global Score

  Gives an idea of the overall performance of the closed-loop system, was calculated as the sum of MDAPE and wobble divided by the fraction of time BIS was within ±10 of the target.

  approx 8 hrs

Secondary Outcomes (12)

• propofol consumption

  approx 8 hrs

• induction time

  approx 8 hrs

• fentanyl used

  approx 8 hrs

• phenylephrine use

  approx 8 hrs

• adrenaline use

  approx 8 hrs

Study Arms (2)

Target Controlled Infusion

EXPERIMENTAL

Propofol is administered through a target controlled infusion pump based on Marsh model to achieve a BIS of 50 and manually adjusted to maintain BIS between 40 and 60

Device: Target Controlled Infusion

Closed Loop Anesthesia Delivery System

ACTIVE COMPARATOR

Propofol is administered through Closed Loop Anesthesia Delivery System which is titrated automatically to achieve a target BIS of 50 and maintain it between 40 and 60.

Device: Closed Loop Anesthesia Delivery System

Interventions

Target Controlled Infusion DEVICE

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

Target Controlled Infusion

Closed Loop Anesthesia Delivery System DEVICE

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

Closed Loop Anesthesia Delivery System

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Left ventricular ejection fraction ≤45%
• NYHA III/IV
• ASA III/IV
• Undergoing CABG or valve replacement surgeries

You may not qualify if:

• Patients with body mass index (BMI)\>30 kg.m2and \<15 kg.m2.
• Patients with LVEF≥45%
• Patients already on inotropes
• Anticipated difficult airway
• Central nervous system disease
• Psychiatric disorder
• Liver disease

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Related Publications (1)

• Mahajan V, Samra T, Puri GD; Head of Department of Anesthesia. Anaesthetic depth control using closed loop anaesthesia delivery system vs. target controlled infusion in patients with moderate to severe left ventricular systolic dysfunction. J Clin Anesth. 2017 Nov;42:106-113. doi: 10.1016/j.jclinane.2017.07.014. Epub 2017 Aug 31.

  PMID: 28865915 DERIVED

Study Officials

• Varun Mahajan, MBBS

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

• Tanvir Samra, MD

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

• Goverdhan D Puri, MD, PhD

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MBBS

Study Record Dates

• First Submitted: January 1, 2016
• First Posted: January 5, 2016
• Study Start: July 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 5, 2016

Record last verified: 2016-01