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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Device: Bispectral Index

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group BIS; Thiopentone dosing during induction of anaesthesia based on guidance of Bispectral Index values.	Device: 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.
NO_INTERVENTION: 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: National Institute of Mental Health and Neuro Sciences, India
• Investigators: Study Chair: Muthuchellappan Radhakrishnan, MD, DM, National Institute of Mental Health and Neuro Sciences, India

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2016
• Primary Completion (ACTUAL): May 30, 2017
• Study Completion (ACTUAL): June 15, 2017

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: March 21, 2018
• First Posted (ACTUAL): March 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 21, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Bispectral Index
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Craniocerebral Trauma
• Other Study ID Numbers: NIMHANS/DO/103rd IEC/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No