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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Device: Bispectral Index


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group BIS<br>Thiopentone dosing during induction of anaesthesia based on guidance of Bispectral Index values. | Device: Bispectral Index<br>* 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.<br>|
| No Intervention: Group Clinical<br>Thiopentone dosing during induction of anaesthesia based on clinical guidance targeted to loss of eyelash reflex or loss of response to noxious stimulus. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thiopentone requirement | Difference of thiopentone requirement with and without use of Bispectral Index guidance during induction of anaesthesia in traumatic brain injury patients. | Beginning of anaesthetic induction till End of anaesthetic induction | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bispectral Index