NCT03480880

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: National Institute of Mental Health and Neuro Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-05-30
• Completion: 2017-06-15
• First posted: 2018-03-29
• Last updated: 2018-03-29