Closed Loop Propofol Administration in Pediatric Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
INDRANIL BISWAS, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01600287
First received: May 11, 2012
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

The purpose of the study is to evaluate and compare the feasibility, efficacy and safety of IAADS (Improved Anaesthetic Agent Delivery System) for propofol anaesthesia against manual control using bispectral index in paediatric patients undergoing open heart surgery under cardio-pulmonary bypass.


Condition Intervention
Pediatric Cardiac Surgery
Intraoperative Awareness
Automated Drug Delivery
Other: IAADS
Other: Manual propofol administration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Evaluation of Closed Loop Anaesthesia Delivery System for Propofol Anaesthesia in Pediatric Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Percentage of Time Bispectral Index(BIS) Remains+/-10 of Target [ Time Frame: Approximately 8 hours ] [ Designated as safety issue: No ]
    The primary outcome to be measured is the ability of the system to keep the depth of anesthesia in the target range, i.e, Bispectral Index(BIS) value of 50+/- 10. This will assess the ability of the system to prevent intra-operative awareness of the patients and at the same time avoid excessive depth of anesthesia with its accompanying adverse effects.


Secondary Outcome Measures:
  • Median Performance Error(MDPE) [ Time Frame: Approximately 8 hours ] [ Designated as safety issue: No ]
    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.

  • Median Absolute Performance Error(MDAPE) [ Time Frame: Approximately 8 hours ] [ Designated as safety issue: No ]
    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 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.

  • Wobble [ Time Frame: Approximately 8 hours ] [ Designated as safety issue: No ]
    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.

  • Percentage of Time Heart Rate Remains Within 25% of Pre-op Baseline [ Time Frame: Approximately 8 hours ] [ Designated as safety issue: Yes ]
    The duration of time heart rate remains within 25% of the pre-operative baseline value during the period propofol (general anesthetic) is 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.

  • Percentage of Time Mean Arterial Pressure Remains Within 25% of Pre-op Baseline [ Time Frame: Approximately 8 hours ] [ Designated as safety issue: Yes ]
    The duration of time mean arterial pressure remains within 25% of the pre-operative baseline value during the period propofol (general anesthetic) is administered to the study population. This value is expressed as percentage. This outcome is expressed as the mean of percentage of time per participant

  • Intra-operative Awareness [ Time Frame: Approximately 3 days and then 1 month later ] [ Designated as safety issue: Yes ]
    The number of patients who will be able to recall the intra-operative events when assessed postoperatively. This will be assessed by a structured protocol

  • Divergence [ Time Frame: 8 hours (approx) ] [ Designated as safety issue: No ]
    slope of the linear regression curve of performance error against time.

  • Global Score [ Time Frame: 8 hours (approx) ] [ Designated as safety issue: No ]
    overall performance assessment of the system calculated as= [(MDAPE+Wobble)/percentage of time BIS remains within target]x100 Lower score indicates better overall performance

  • Intraoperative Phenylephrine Used (Pre CPB) [ Time Frame: 2 hours(approx) ] [ Designated as safety issue: No ]
    total phenylephrine dose needed to be used in the pre CPB period to maintain hemodynamic stability


Other Outcome Measures:
  • Induction Dose of Propofol [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    Dose of propofol needed for induction

  • Induction Time [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    Time required for the first time achievement of two subsequent BIS values below or equal to 55

  • Minimum BIS During Induction [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    Bispectral Index(BIS) is an EEG-based objective measure of anesthetic depth with values ranging from 100 to 0, lower number indicating greater depth of anesthesia. Values between 40 to 60 indicate adequate depth required for surgery. During induction of anesthesia, there is a tendency of overshooting the adequate depth of anesthesia, due to use of higher dose and rate of administration required for induction. The minimum BIS achieved during induction is a measure of this overshoot. The less the minimum value, the more is the overshoot, worse the outcome is. The minimum BIS during induction is automatically stored in the PC used for the study.

  • Percentage Fall in MAP During Induction [ Time Frame: 15 minutes ] [ Designated as safety issue: Yes ]
    percentage fall in mean arterial pressure from baseline during induction

  • Total Propofol Used (mg/kg/hr) [ Time Frame: 8 hours (approx) ] [ Designated as safety issue: No ]
    total propofol used based on per kg body weight per hour for the whole duration of surgery

  • Total Fentanyl Used (µg/kg) [ Time Frame: 8 hours(approx) ] [ Designated as safety issue: No ]
    total fentanyl used in the whole duration of surgery on per kg body weight basis

  • Total Off CPB Propofol Used (mg/kg/hr [ Time Frame: 6 hours(approx) ] [ Designated as safety issue: No ]
    total dosage of propofol used on per kg body weight per hour basis in the period before and after cardiopulmonary bypass period.

  • Number of Times Rate of Propofol Changed Manually [ Time Frame: 8 hours(aprrox) ] [ Designated as safety issue: No ]
    Number of times rate of propofol needed to be changed manually


Enrollment: 40
Study Start Date: January 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IAADS group
dosage of propofol adjusted automatically by IAADS
Other: IAADS
In automatic mode, the system requests an update of the BIS data every 5 seconds and calculates the BIS "error" (difference between the target and actual BIS value). This value along with the trends of BIS in the epoch of the last 30 seconds as well as in the last 5 minutes is passed on to a patient individualized, model based adaptive control algorithm. The algorithm uses the error to calculate an adjustment to the propofol delivery rate, but does not apply it immediately. Adjustments to the propofol delivery rate are only made every 30 seconds, taking into account the sum of previous six BIS "error" values, the trends of BIS in the epoch of last 30 seconds as well as in the last 5 minutes, time elapsed since the initiation of infusion, pharmacokinetics, the time delay factor between sensing and averaging of BIS data, the time delay factor between the change in infusion rate and the actual change in the plasma concentration of propofol as well as the peak effect of propofol.
Active Comparator: Manual group
dosage of propofol adjusted manually
Other: Manual propofol administration
In "manual" mode, the user can also control the propofol infusion rate manually, using the keyboard or the mouse of the PC. The PC displays a graph of the propofol delivery rate and trend of BIS value.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children, aged 5-18 years and ASA (American Society of Anesthesiology) physical status 2-3, planned for elective open heart surgery under general anaesthesia.

Exclusion Criteria:

  • Patients weighing more than ±30% of ideal body weight.
  • Patients having neurological/psychological disorders or on psychoactive medications.
  • Patients belonging to NYHA (New York Heart Association) class IV.
  • Patients with severe stenotic valvular lesions, eg, mitral or aortic stenosis.
  • Patients with known allergy to propofol or any of its constituents.
  • Patients having severe pulmonary arterial hypertension.
  • Patients with cyanotic congenital heart disease.
  • Patients requiring deep hypothermic circulatory arrest during surgery.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600287

Locations
India
Advanced Cardiac Centre.Postgraduate Institute of Medical Education and Research.
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: Indranil Biswas, MBBS Postgraduate Institute of Medical Education and Research
Principal Investigator: Goverdhan D Puri, MBBS,MD,PhD Postgraduate Institute of Medical Education and Research
Principal Investigator: Preethy J Mathew, MBBS,MD Postgraduate Institute of Medical Education and Research
  More Information

Publications:
Responsible Party: INDRANIL BISWAS, Indranil Biswas, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01600287     History of Changes
Other Study ID Numbers: 8450/PG-2Trg/2010/
Study First Received: May 11, 2012
Results First Received: December 22, 2012
Last Updated: July 10, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Postgraduate Institute of Medical Education and Research:
bispectral index
propofol
paediatric cardiac surgery
closed loop anaesthesia delivery system

Additional relevant MeSH terms:
Intraoperative Awareness
Intraoperative Complications
Pathologic Processes
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 16, 2014