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Completed

NCT Number: NCT03480880

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

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bispectral Index

Device

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

National Institute of Mental Health and Neuro Sciences, India

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 29, 2018
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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