A Phase 4 interventional study of Bispectral Index in Traumatic Brain Injury, sponsored by National Institute of Mental Health and Neuro Sciences, India. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-03-29.
Sponsored by National Institute of Mental Health and Neuro Sciences, India · Phase 4, Interventional, and Treatment
This study was conducted in two parts:
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.
Exclusion Criteria:
Thiopentone dosing during induction of anaesthesia based on guidance of Bispectral Index values.
Device: Bispectral Index
Thiopentone dosing during induction of anaesthesia based on clinical guidance targeted to loss of eyelash reflex or loss of response to noxious stimulus.
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.
Thiopentone requirement
Difference of thiopentone requirement with and without use of Bispectral Index guidance during induction of anaesthesia in traumatic brain injury patients.
Time frame: Beginning of anaesthetic induction till End of anaesthetic induction
Intraoperative Bispectral Index changes
Observation of Bispectral Index changes during craniotomy and decompression.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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National Institute of Mental Health and Neuro Sciences, India