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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03480880
• Other study ID #: NIMHANS/DO/103rd IEC/2016
• Status: Completed
• Phase: Phase 4
• First received: March 21, 2018
• Last updated: March 21, 2018
• Start date: October 1, 2016
• Est. completion date: June 15, 2017

Study information

• Verified date: March 2018
• Source: National Institute of Mental Health and Neuro Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 15, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Craniocerebral Trauma
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health and Neuro Sciences, India

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.