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

NCT ID: NCT03480880

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2017-06-15

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group BIS

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

Group Type: EXPERIMENTAL

Bispectral Index

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health and Neuro Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Dhritiman Chakrabarti

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muthuchellappan Radhakrishnan, MD, DM

Role: STUDY_CHAIR

National Institute of Mental Health and Neuro Sciences, India

Other Identifiers

NIMHANS/DO/103rd IEC/2016

Identifier Type: -

Identifier Source: org_study_id