Traumatic Brain Injury
Conditions
Keywords
Bispectral Index
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.
Interventions
DEVICEBispectral 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.
Sponsors
National Institute of Mental Health and Neuro Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
1. Anaesthetic care provider in one arm of first part of study was blinded to intraoperative changes in Bispectral index. 2. Anaesthetic care provider was blinded to Bispectral Index changes in second part of study.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thiopentone requirement | Beginning of anaesthetic induction till End of anaesthetic induction | Difference of thiopentone requirement with and without use of Bispectral Index guidance during induction of anaesthesia in traumatic brain injury patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Bispectral Index changes | Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit. | Observation of Bispectral Index changes during craniotomy and decompression. |
| Intraoperative Systolic blood pressure changes | Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit. | Observation of Systolic blood pressure changes during craniotomy and decompression. |
| Intraoperative Mean blood pressure changes | Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit. | Observation of Mean blood pressure changes during craniotomy and decompression. |
| Intraoperative heart rate changes | Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit. | Observation of heart rate changes during craniotomy and decompression. |
Outcome results
None listed