| CTRI Number |
CTRI/2025/07/090036 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
19/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
CHANGES IN THE PROPERTIES OF THE BLOOD VESSELS OF THE BRAIN CAUSED BY INHALATIONAL ANAESTHETIC AGENTS AND INFLUENCE OF THESE CHANGES ON BRAIN CONDIITONS DURING THE SURGERY IN PATIENTS UNDERGOING SURGICAL REMOVAL OF BRAIN TUMOR GLIOMA |
|
Scientific Title of Study
|
Changes in cerebral vasodilation induced by sevoflurane, isoflurane, desflurane and the influence of these changes on intraoperative brain conditions in patients undergoing resection of gliomas under general anaesthesia- A Randomised Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr RAKSHA ANAND |
| Designation |
SENIOR RESIDENT |
| Affiliation |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES |
| Address |
DEPARTMENT OF NEUROANAESTHESIA AND NEUROCRITICAL CARE,
NIMHANS,
BENGALURU
Bangalore KARNATAKA 560029 India |
| Phone |
8660713746 |
| Fax |
|
| Email |
raksha6174@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr SUDHIR V |
| Designation |
PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES |
| Address |
DEPARTMENT OF NEUROANAESTHESIA AND NEUROCRITICAL CARE,
NIMHANS
BANGALORE
Bangalore KARNATAKA 560029 India |
| Phone |
9900793108 |
| Fax |
|
| Email |
vsudhir77@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr SUDHIR V |
| Designation |
PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES |
| Address |
DEPARTMENT OF NEUROANAESTHESIA AND NEUROCRITICAL CARE,
NIMHANS
BANGALORE
Bangalore KARNATAKA 560029 India |
| Phone |
9900793108 |
| Fax |
|
| Email |
vsudhir77@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES |
| Address |
Nimhans, Hosur Main Road, Hombegowda nagar, Lakkasandra, Wilson Garden, Bengaluru, Karnataka 560029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR RAKSHA ANAND |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES |
DEPARTMENT OF NEUROANAESTHESIA AND NEUROCRITICAL CARE,
NIMHANS,
BENGALURU 560029 Bangalore KARNATAKA |
86607 13746
raksha6174@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
TRANSCRANIAL DOPPLER AND SUBDURAL PRESSURE MONITORING |
THE CHANGES IN THE TCD PARAMETERS WITH RESPECT TO MCA FLOW VELOCITIES AMONGST 1.O MAC CONCENTRATION OF THREE COLATILE AGENTS WILL BE ASSESSED AND CORRELATED WITH THE INTRAOPERATIVE BRAIN RELAXATION USING SUBDURAL PRESSURE MONITORING IN PATIENTS WITH UNILATERAL GLIOMA. |
| Comparator Agent |
TRANSCRANIAL DOPPLER AND SUBDURAL PRESSURE MONITORING |
THE CHANGES IN THE TCD PARAMETERS WITH RESPECT TO MCA FLOW VELOCITIES AMONGST 1.O MAC CONCENTRATION OF THREE COLATILE AGENTS WILL BE ASSESSED AND CORRELATED WITH THE INTRAOPERATIVE BRAIN RELAXATION USING SUBDURAL PRESSURE MONITORING IN PATIENTS WITH UNILATERAL GLIOMA. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with Supratentorial Lesion glioma only.
2.Age group 18 to 60 years.
3.ASA physical grade I and II. |
|
| ExclusionCriteria |
| Details |
1.Patients with poor acoustic temporal window.
2.Hemodynamically unstable patient requiring inotropic infusion.
3.Plaques or Stenosis observed on Carotid Artery Doppler in the preoperative period.
4.Midline shift of more than 5mm.
5.Refusal of Consent. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To correlate changes in Transcranial doppler parameters with 1 MAC concentration of sevoflurane, isoflurane and desflurane with:
A) intraoperative brain relaxation score (subjective) B) Sub dural pressure measurement (objective) |
the primary outcome will be measured with a baseline transcranial doppler parameters prior to induction of anaesthesia, fifteen minutes post induction of anaesthesia and subdural pressure will be monitored post craniotomy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effect of all three inhalational agents on 1.hemoglobin mass loss in the intra-operative period.
2.The compare the effect of all three inhalational agents on emergence delirium and post operative delirium |
The intraoperative blood loss is calculated by the haemoglobin mass loss formula which considers the following three parameters:
1.Patient’s pre-operative hemoglobin analysed by HemoCue
2.Patient’s post-operative hemoglobin analysed by HemoCue
3.Patients’s estimated blood volume.
Patient’s postoperative hemoglobin will be measured in the immediate postoperative period (0 hrs), 12 hrs and 24hrs postoperatively and the lowest among the three values will be considered.
This will be assessed using confusion assessment score for three post operative days |
|
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Target Sample Size
|
Total Sample Size="126" Sample Size from India="126"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [raksha6174@gmail.com].
- For how long will this data be available start date provided 01-07-2027 and end date provided 01-07-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Inhalational agents in today’s clinical practice alter the cerebral hemodynamics in a dose dependent fashion. Upwards of 1.0 MAC concentration cerebral vasodilatation is seen as intrinsic vasodilatory action of the volatile agents as well as decreased cerebral resistance. The magnitude of cerebral vasodilatation is not uniform amongst the three widely used inhalational agents as shown by both human and animal studies. Cerebral vasodilatation is known to alter cerebral hemodynamics. Adequate brain relaxation is essential for neurosurgery to provide sufficient surgical exposure thereby minimising the risk of damage to the normal brain tissue. Presence of supratentorial tumors may impair cerebral autoregulation more so if the midline shift is more than 5 mm. As estimated by the neurosurgeons, subdural pressure monitoring after removal of bone flap correlates well with the dural tension. There are lack of methods by which cerebral blood flow (CBF) can be measured directly. There are lack of methods by which cerebral blood flow can be measured directly. However, CBF can be indirectly measured by trans-cranial doppler (TCD) . When angle of insonation and vessel diameter remains constant, the middle cerebral artery (MCA) flow velocity provides an indirect measure of cerebral blood flow. Cerebral blood flow changes due to volatile agents can be assessed by the MCA flow velocity as change in the MCA flow velocity is directly proportional to the change in CBF and TCD is a surrogate of CBF. Pulsatility index (PI) is a non-invasive method of assessing vascular resistance in major blood vessels with the use of Doppler ultrasonography. PI more than 1.5 in Middle Cerebral artery using Transcranial Doppler has been shown to be an indicator of increased Intracranial Pressure. A previous unpublished study has shown that Isoflurane has a better cerebral hemodynamic profile amongst the three inhalational agents viz. Isoflurane, Desflurane and sevoflurane with respect to TCD study of MCA flow velocities at equi-MAC concentrations under steady state anesthesia. However, does the same observation translate into clinical results with respect to intraoperative brain condition was not studied in the previous study. Hence, we propose to conduct a randomized controlled trial to test the clinical translation. In this randomized control trial, we propose to assess the changes in MCA flow velocities amongst the three volatile agents and correlating the findings with the intraoperative brain condition by using the brain relaxation score and subdural pressure measurements in patients with unilateral glioma (supratentorial tumor).
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