Clinical trial NCT03480880: Bispectral Index Value Changes During Induction and Surgical Decompression in Head Injury Patients
Official title: Bispectral Index Value Changes During Induction and Surgical Decompression in Head Injury Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Traumatic Brain Injury
Keywords: Bispectral Index
Lead sponsor: National Institute of Mental Health and Neuro Sciences, India
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Inj. Thiopentone dose requirement for induction of anaesthesia with and without the use of Bispectral Index guidance.
2. Observation of Bispectral Index change in intraoperative period.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Thiopentone requirement
timeFrame: Beginning of anaesthetic induction till End of anaesthetic induction
Secondary outcomes:
measure: Intraoperative Bispectral Index changes
timeFrame: Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.
measure: Intraoperative Systolic blood pressure changes
timeFrame: Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.
measure: Intraoperative Mean blood pressure changes
timeFrame: Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.
measure: Intraoperative heart rate changes
timeFrame: Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.
Other outcomes:
Locations:
Study officials:
affiliation: National Institute of Mental Health and Neuro Sciences, India
name: Muthuchellappan Radhakrishnan, MD, DM
role: STUDY_CHAIR
References: