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

Phase 4

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Device: Bispectral Index

• Registration Number: NCT03480880
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-10-01
• Primary Completion: 2017-05-30
• Study Completion: 2017-06-15
• Status Verified: 2018-03
• Study First Submitted: 2018-03-21
• Study First Submitted QC: 2018-03-21
• Last Update Submitted: 2018-03-21
• Study First Posted: 2018-03-29
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group BIS	Bispectral Index	Thiopentone dosing during induction of anaesthesia based on guidance of Bispectral Index values.

Primary Outcome Measures

Name	Time	Method
Thiopentone requirement	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

Name	Time	Method
Intraoperative Mean blood pressure changes	Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.	Observation of Mean blood pressure changes during craniotomy and decompression.
Intraoperative Bispectral Index changes	Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.	Observation of Bispectral Index changes during craniotomy and decompression.
Intraoperative Systolic blood pressure changes	Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.	Observation of Systolic blood pressure changes during craniotomy and decompression.
Intraoperative heart rate changes	Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.	Observation of heart rate changes during craniotomy and decompression.