Bispectral Index Value Changes During Induction and Surgical Decompression in Head Injury Patients
Primary Purpose
Traumatic Brain Injury
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bispectral Index
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Bispectral Index
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group BIS
Group Clinical
Arm Description
Thiopentone dosing during induction of anaesthesia based on guidance of Bispectral Index values.
Thiopentone dosing during induction of anaesthesia based on clinical guidance targeted to loss of eyelash reflex or loss of response to noxious stimulus.
Outcomes
Primary Outcome Measures
Thiopentone requirement
Difference of thiopentone requirement with and without use of Bispectral Index guidance during induction of anaesthesia in traumatic brain injury patients.
Secondary Outcome Measures
Intraoperative Bispectral Index changes
Observation of Bispectral Index changes during craniotomy and decompression.
Intraoperative Systolic blood pressure changes
Observation of Systolic blood pressure changes during craniotomy and decompression.
Intraoperative Mean blood pressure changes
Observation of Mean blood pressure changes during craniotomy and decompression.
Intraoperative heart rate changes
Observation of heart rate changes during craniotomy and decompression.
Full Information
NCT ID
NCT03480880
First Posted
March 21, 2018
Last Updated
March 21, 2018
Sponsor
National Institute of Mental Health and Neuro Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT03480880
Brief Title
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
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
June 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Mental Health and Neuro Sciences, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study was conducted in two parts:
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Bispectral Index
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Inj. Thiopentone dose requirement for induction of anaesthesia with and without the use of Bispectral Index guidance.
Observation of Bispectral Index change in intraoperative period.
Masking
ParticipantCare Provider
Masking Description
Anaesthetic care provider in one arm of first part of study was blinded to intraoperative changes in Bispectral index.
Anaesthetic care provider was blinded to Bispectral Index changes in second part of study.
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group BIS
Arm Type
Experimental
Arm Description
Thiopentone dosing during induction of anaesthesia based on guidance of Bispectral Index values.
Arm Title
Group Clinical
Arm Type
No Intervention
Arm Description
Thiopentone dosing during induction of anaesthesia based on clinical guidance targeted to loss of eyelash reflex or loss of response to noxious stimulus.
Intervention Type
Device
Intervention Name(s)
Bispectral Index
Intervention Description
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.
Primary Outcome Measure Information:
Title
Thiopentone requirement
Description
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
Secondary Outcome Measure Information:
Title
Intraoperative Bispectral Index changes
Description
Observation of Bispectral Index changes during craniotomy and decompression.
Time Frame
Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.
Title
Intraoperative Systolic blood pressure changes
Description
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.
Title
Intraoperative Mean blood pressure changes
Description
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.
Title
Intraoperative heart rate changes
Description
Observation of heart rate changes during craniotomy and decompression.
Time Frame
Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muthuchellappan Radhakrishnan, MD, DM
Organizational Affiliation
National Institute of Mental Health and Neuro Sciences, India
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bispectral Index Value Changes During Induction and Surgical Decompression in Head Injury Patients
We'll reach out to this number within 24 hrs