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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  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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. 
 
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. 
 
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 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. 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

  3. 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.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [raksha6174@gmail.com].

  6. 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.

  7. 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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