Traumatic Brain InjuryPhase 4NCT03480880
Bispectral Index Value Changes During Induction and Surgical Decompression in Head Injury Patients
A Phase 4 study testing Bispectral Index in people with Traumatic Brain Injury, run by National Institute of Mental Health and Neuro Sciences, India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Bispectral Index
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 15 Jun 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Head injury patients coming for surgery
Who cannot join
- Hypotension/Arrythmias at time of induction
- Extra Dural Hemorrhage
- Extracranial injuries
- Scalp lacerations
- History of Seizures
- No consent
About this study
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.
Read the 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
- Being tested
- Bispectral Index
- Keywords
- Bispectral Index
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispectral IndexDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group BIS | Experimental | Thiopentone dosing during induction of anaesthesia based on guidance of Bispectral Index values. Receives: Device: Bispectral Index |
| Group Clinical | No intervention | Thiopentone dosing during induction of anaesthesia based on clinical guidance targeted to loss of eyelash reflex or loss of response to noxious stimulus. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thiopentone requirement
Difference of thiopentone requirement with and without use of Bispectral Index guidance during induction of anaesthesia in traumatic brain injury patients.
Measured: Beginning of anaesthetic induction till End of anaesthetic induction
Secondary outcomes (4)
Intraoperative Bispectral Index changes
Observation of Bispectral Index changes during craniotomy and decompression.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Oct 2016
- Primary completion30 May 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health and Neuro Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dhritiman Chakrabarti, National Institute of Mental Health and Neuro Sciences, India
- Investigators
- Muthuchellappan Radhakrishnan, MD, DM, Study chair, National Institute of Mental Health and Neuro Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480880
- Sponsor's protocol ID
- NIMHANS/DO/103rd IEC/2016
- Status last verified
- Mar 2018
- First submitted
- 21 Mar 2018
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bispectral Index Value Changes During Induction and Surgical Decompression in Head Injury Patients
- ClinicalTrials.gov ID
- NCT03480880
- Acronym / sponsor ID
- NIMHANS/DO/103rd IEC/2016
- Conditions
- Traumatic Brain Injury
- Keywords
- Bispectral Index
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Institute of Mental Health and Neuro Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group BIS | Experimental | Device: Bispectral IndexThiopentone dosing during induction of anaesthesia based on guidance of Bispectral Index values. |
| Group Clinical | No intervention | –Thiopentone dosing during induction of anaesthesia based on clinical guidance targeted to loss of eyelash reflex or loss of response to noxious stimulus. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Head injury patients coming for surgery
Key exclusion criteria (6 listed)
- Hypotension/Arrythmias at time of induction
- Extra Dural Hemorrhage
- Extracranial injuries
- Scalp lacerations
- History of Seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bispectral IndexThiopentone 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. | Device | Group BIS |
Primary outcome
Thiopentone requirement
Time frame: 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.
4 secondary outcomes
Intraoperative Bispectral Index changes
Time frame: Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.
Intraoperative Systolic blood pressure changes
Time frame: Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.
Intraoperative Mean blood pressure changes
Time frame: Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.
Intraoperative heart rate changes
Time frame: Beginning of anaesthetic Induction till patient is shifted to post-anaesthesia care unit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muthuchellappan Radhakrishnan, MD, DM study chair
National Institute of Mental Health and Neuro Sciences, India
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bispectral Index in people with Traumatic Brain Injury, run by National Institute of Mental Health and Neuro Sciences, India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thiopentone requirement (time frame: Beginning of anaesthetic induction till End of anaesthetic induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.