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

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ClinicalTrials.gov Identifier: NCT03480880
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Dhritiman Chakrabarti, National Institute of Mental Health and Neuro Sciences, India

Brief Summary:

This study was conducted in two parts:

  1. 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.
  2. 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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Device: Bispectral Index Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  1. Inj. Thiopentone dose requirement for induction of anaesthesia with and without the use of Bispectral Index guidance.
  2. Observation of Bispectral Index change in intraoperative period.
Masking: Double (Participant, Care Provider)
Masking Description:
  1. Anaesthetic care provider in one arm of first part of study was blinded to intraoperative changes in Bispectral index.
  2. Anaesthetic care provider was blinded to Bispectral Index changes in second part of study.
Primary Purpose: Treatment
Official Title: Bispectral Index Value Changes During Induction and Surgical Decompression in Head Injury Patients
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : May 30, 2017
Actual Study Completion Date : June 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Head Injuries

Arm Intervention/treatment
Experimental: Group BIS
Thiopentone dosing during induction of anaesthesia based on guidance of Bispectral Index values.
Device: Bispectral Index
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.

No Intervention: Group Clinical
Thiopentone dosing during induction of anaesthesia based on clinical guidance targeted to loss of eyelash reflex or loss of response to noxious stimulus.



Primary Outcome Measures :
  1. Thiopentone requirement [ Time Frame: Beginning of anaesthetic induction till End of anaesthetic induction ]
    Difference of thiopentone requirement with and without use of Bispectral Index guidance during induction of anaesthesia in traumatic brain injury patients.


Secondary Outcome Measures :
  1. Intraoperative Bispectral Index changes [ Time Frame: Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit. ]
    Observation of Bispectral Index changes during craniotomy and decompression.

  2. Intraoperative Systolic blood pressure changes [ Time Frame: Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit. ]
    Observation of Systolic blood pressure changes during craniotomy and decompression.

  3. Intraoperative Mean blood pressure changes [ Time Frame: Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit. ]
    Observation of Mean blood pressure changes during craniotomy and decompression.

  4. Intraoperative heart rate changes [ Time Frame: Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit. ]
    Observation of heart rate changes during craniotomy and decompression.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480880


Sponsors and Collaborators
National Institute of Mental Health and Neuro Sciences, India
Investigators
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Study Chair: Muthuchellappan Radhakrishnan, MD, DM National Institute of Mental Health and Neuro Sciences, India

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Responsible Party: Dhritiman Chakrabarti, Assistant Professor, National Institute of Mental Health and Neuro Sciences, India
ClinicalTrials.gov Identifier: NCT03480880     History of Changes
Other Study ID Numbers: NIMHANS/DO/103rd IEC/2016
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dhritiman Chakrabarti, National Institute of Mental Health and Neuro Sciences, India:
Bispectral Index
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Craniocerebral Trauma
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Thiopental
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anticonvulsants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action