NCT01600287

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 17, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
8 months until next milestone

Results Posted

Study results publicly available

August 9, 2013

Completed
Last Updated

August 9, 2013

Status Verified

July 1, 2013

Enrollment Period

11 months

First QC Date

May 11, 2012

Results QC Date

December 22, 2012

Last Update Submit

July 10, 2013

Conditions

Pediatric Cardiac SurgeryIntraoperative AwarenessAutomated Drug Delivery

Keywords

bispectral indexpropofolpaediatric cardiac surgeryclosed loop anaesthesia delivery system

Outcome Measures

Primary Outcomes (1)

  • Percentage of Time Bispectral Index(BIS) Remains+/-10 of Target

    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.

    Approximately 8 hours

Secondary Outcomes (9)

  • Median Performance Error(MDPE)

    Approximately 8 hours

  • Median Absolute Performance Error(MDAPE)

    Approximately 8 hours

  • Wobble

    Approximately 8 hours

  • Percentage of Time Heart Rate Remains Within 25% of Pre-op Baseline

    Approximately 8 hours

  • Percentage of Time Mean Arterial Pressure Remains Within 25% of Pre-op Baseline

    Approximately 8 hours

  • +4 more secondary outcomes

Other Outcomes (8)

  • Induction Dose of Propofol

    10 minutes

  • Induction Time

    10 minutes

  • Minimum BIS During Induction

    15 minutes

  • +5 more other outcomes

Study Arms (2)

IAADS group

EXPERIMENTAL

dosage of propofol adjusted automatically by IAADS

Other: IAADS

Manual group

ACTIVE COMPARATOR

dosage of propofol adjusted manually

Other: Manual propofol administration

Interventions

IAADSOTHER

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.

IAADS group
Manual propofol administrationOTHER

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.

Manual group

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advanced Cardiac Centre.Postgraduate Institute of Medical Education and Research.

Chandigarh, Chandigarh, 160012, India

Location

Related Publications (3)

  • Agarwal J, Puri GD, Mathew PJ. Comparison of closed loop vs. manual administration of propofol using the Bispectral index in cardiac surgery. Acta Anaesthesiol Scand. 2009 Mar;53(3):390-7. doi: 10.1111/j.1399-6576.2008.01884.x.

    PMID: 19243324BACKGROUND

  • Solanki A, Puri GD, Mathew PJ. Bispectral index-controlled postoperative sedation in cardiac surgery patients: a comparative trial between closed loop and manual administration of propofol. Eur J Anaesthesiol. 2010 Aug;27(8):708-13. doi: 10.1097/EJA.0b013e328335b2d4.

    PMID: 20299990BACKGROUND

  • Puri GD, Kumar B, Aveek J. Closed-loop anaesthesia delivery system (CLADS) using bispectral index: a performance assessment study. Anaesth Intensive Care. 2007 Jun;35(3):357-62. doi: 10.1177/0310057X0703500306.

    PMID: 17591128BACKGROUND

MeSH Terms

Conditions

Intraoperative Awareness

Condition Hierarchy (Ancestors)

Intraoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

anesthesiologist could get visual impression of his performance.

Results Point of Contact

Title
Dr G D Puri
Organization
Postgraduate Institute of Medical Education and Research
gdpuri007@hotmail.com
00919914209509

Study Officials

  • Indranil Biswas, MBBS

    Post Graduate Institute of Medical Education and Research, Chandigarh

    PRINCIPAL INVESTIGATOR

  • Goverdhan D Puri, MBBS,MD,PhD

    Post Graduate Institute of Medical Education and Research, Chandigarh

    PRINCIPAL INVESTIGATOR

  • Preethy J Mathew, MBBS,MD

    Post Graduate Institute of Medical Education and Research, Chandigarh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Indranil Biswas

Study Record Dates

First Submitted

May 11, 2012

First Posted

May 17, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

August 9, 2013

Results First Posted

August 9, 2013

Record last verified: 2013-07

Locations

IN(1)