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Bispectral Index Value Changes During Induction and Surgical Decompression in Head Injury Patients

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bispectral Index
Sponsored by
National Institute of Mental Health and Neuro Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Bispectral Index

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Head injury patients coming for surgery

Exclusion Criteria:

  • Hypotension/Arrythmias at time of induction
  • Extra Dural Hemorrhage
  • Extracranial injuries
  • Scalp lacerations
  • History of Seizures
  • No consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Group BIS

    Group Clinical

    Arm Description

    Thiopentone dosing during induction of anaesthesia based on guidance of Bispectral Index values.

    Thiopentone dosing during induction of anaesthesia based on clinical guidance targeted to loss of eyelash reflex or loss of response to noxious stimulus.

    Outcomes

    Primary Outcome Measures

    Thiopentone requirement
    Difference of thiopentone requirement with and without use of Bispectral Index guidance during induction of anaesthesia in traumatic brain injury patients.

    Secondary Outcome Measures

    Intraoperative Bispectral Index changes
    Observation of Bispectral Index changes during craniotomy and decompression.
    Intraoperative Systolic blood pressure changes
    Observation of Systolic blood pressure changes during craniotomy and decompression.
    Intraoperative Mean blood pressure changes
    Observation of Mean blood pressure changes during craniotomy and decompression.
    Intraoperative heart rate changes
    Observation of heart rate changes during craniotomy and decompression.

    Full Information

    First Posted
    March 21, 2018
    Last Updated
    March 21, 2018
    Sponsor
    National Institute of Mental Health and Neuro Sciences, India
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03480880
    Brief Title
    Bispectral Index Value Changes During Induction and Surgical Decompression in Head Injury Patients
    Official Title
    Bispectral Index Value Changes During Induction and Surgical Decompression in Head Injury Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2016 (Actual)
    Primary Completion Date
    May 30, 2017 (Actual)
    Study Completion Date
    June 15, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Institute of Mental Health and Neuro Sciences, India

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study was conducted in two parts: This first part was designed to determine thiopentone dose requirement for induction of anaesthesia with and without the use of Bispectral Index monitoring - Participant and Care Provider in appropriate study arm blinded. As a secondary outcome, Bispectral index monitoring was used to observe changes in neuronal function in intraoperative period as well as haemodynamic changes intraoperatively - Participant and Care Provider blinded.
    Detailed Description
    Surgery for traumatic brain injury is an anaesthetic challenge fraught with complications such as brain bulge, excessive bleeding, hypotension etc. As yet there are no anaesthetic regimen guidelines to follow for induction of anaesthesia in neurotrauma surgeries. Although the functional effect of anaesthetic agents on neuronal tissue is known quite well, there is lack of studies documenting the effect of these anaesthetic agents on head injured patients. It is also not known whether the requirement of anaesthetic agent in the same as a non head injured patient. This study was designed to assess the requirement of anaesthetic thiopentone in head injured patients and compare the anaesthetic usage with and without Bispectral index (BIS) monitoring. We also observed the real time change in neuronal function using Bispectral Index monitoring after craniotomy, i.e. effectively decompression and release of intracranial pressure intraoperatively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Traumatic Brain Injury
    Keywords
    Bispectral Index

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Inj. Thiopentone dose requirement for induction of anaesthesia with and without the use of Bispectral Index guidance. Observation of Bispectral Index change in intraoperative period.
    Masking
    ParticipantCare Provider
    Masking Description
    Anaesthetic care provider in one arm of first part of study was blinded to intraoperative changes in Bispectral index. Anaesthetic care provider was blinded to Bispectral Index changes in second part of study.
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group BIS
    Arm Type
    Experimental
    Arm Description
    Thiopentone dosing during induction of anaesthesia based on guidance of Bispectral Index values.
    Arm Title
    Group Clinical
    Arm Type
    No Intervention
    Arm Description
    Thiopentone dosing during induction of anaesthesia based on clinical guidance targeted to loss of eyelash reflex or loss of response to noxious stimulus.
    Intervention Type
    Device
    Intervention Name(s)
    Bispectral Index
    Intervention Description
    Thiopentone was administered in 50 mg boluses during induction of anaesthesia, until reduction of Bispectral Index value to less than 50, and total dose of thiopentone recorded.
    Primary Outcome Measure Information:
    Title
    Thiopentone requirement
    Description
    Difference of thiopentone requirement with and without use of Bispectral Index guidance during induction of anaesthesia in traumatic brain injury patients.
    Time Frame
    Beginning of anaesthetic induction till End of anaesthetic induction
    Secondary Outcome Measure Information:
    Title
    Intraoperative Bispectral Index changes
    Description
    Observation of Bispectral Index changes during craniotomy and decompression.
    Time Frame
    Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.
    Title
    Intraoperative Systolic blood pressure changes
    Description
    Observation of Systolic blood pressure changes during craniotomy and decompression.
    Time Frame
    Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.
    Title
    Intraoperative Mean blood pressure changes
    Description
    Observation of Mean blood pressure changes during craniotomy and decompression.
    Time Frame
    Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.
    Title
    Intraoperative heart rate changes
    Description
    Observation of heart rate changes during craniotomy and decompression.
    Time Frame
    Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Head injury patients coming for surgery Exclusion Criteria: Hypotension/Arrythmias at time of induction Extra Dural Hemorrhage Extracranial injuries Scalp lacerations History of Seizures No consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Muthuchellappan Radhakrishnan, MD, DM
    Organizational Affiliation
    National Institute of Mental Health and Neuro Sciences, India
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Bispectral Index Value Changes During Induction and Surgical Decompression in Head Injury Patients

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