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

National Institute of Mental Health and Neuro Sciences, India

Status and phase: Completed; Phase 4

Conditions: Traumatic Brain Injury

Treatments: Device: Bispectral Index

Study type: Interventional

Funder types: Other

Identifiers

NCT03480880

NIMHANS/DO/103rd IEC/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Group BIS

Experimental group

Description:

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

Treatment:

Device: Bispectral Index

Group Clinical

No Intervention group

Description:

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