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CTRI Number  CTRI/2025/08/092695 [Registered on: 08/08/2025] Trial Registered Prospectively
Last Modified On: 08/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Assessing the brain blood flow control and carbon dioxide response before and after supretentorial brain tumor surgery. 
Scientific Title of Study   Perioperative assessment of dynamic cerebral autoregulation and vasomotor reactivity using transcranial doppler in patients undergoing elective craniotomy for supratentorial tumour excision - A Prospective study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jayanth R Seshan 
Designation  Assistant Professor 
Affiliation   
Address  Door no 3, Institute block 2nd floor, Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Gorimedu

Pondicherry
PONDICHERRY
605006
India 
Phone  8424017925  
Fax    
Email  drrjayanth.seshan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sri Hari Vignesh R 
Designation  Senior resident 
Affiliation   
Address  Door no 5, Institute block, 2nd floor, Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Gorimedu

Pondicherry
PONDICHERRY
605006
India 
Phone  9940630956  
Fax    
Email  rsriharivignesh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jayanth R Seshan 
Designation  Assistant Professor 
Affiliation   
Address  Door no 3, Institute block 2nd floor Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Gorimedu

Pondicherry
PONDICHERRY
605006
India 
Phone  8424017925  
Fax    
Email  drrjayanth.seshan@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research intramural fund, Jawaharlal Institute of Postgraduate Medical Education and Research, Gorimedu, Pondicherry,605006, INDIA 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research Intramural fund 
Address  Jawaharlal Institute of Postgraduate Medical Education and Research , Gorimedu, Pondicherry 605006, INDIA 
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 
Jayanth R Seshan  Jawaharlal Institute of Postgraduate Medical Education and Research  Door No 3, Institute block 2nd floor Department of Anaesthesiology and Critical Care.
Pondicherry
PONDICHERRY 
8424017925

drrjayanth.seshan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Jawaharlal Institute of Postgraduate medical education and Research Gorimedu Pondicherry 605006  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C710||Malignant neoplasm of cerebrum, except lobes and ventricles,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA GRADE 1 AND 2
GCS MORE THAN 13
 
 
ExclusionCriteria 
Details  Absence of good bilateral Transcranial doppler windows
Recurrent or Residual intracranial tumours
Hemodynamic instability
Patients requiring ventilatory support before surgery
H/o syncope or carotid artery disease
H/o cerebrovascular accident
Vascular disorders
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess and compare the change in dynamic cerebral autoregulation using THRR before and after supratentorial tumour excision.  Preoperative day and Postoperative day one to five post supretentorial tumour excision. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess & compare the Co2 reactivity, vasomotor reactivity & cerebral vasodilatory reserve before & after supratentorial tumour excision.  Preoperative day & Postoperative day one to five post supretentorial tumour excision. 
To assess the effect of tumour size on cerebral autoregulation pre & post operatively  Preoperative day & Postoperative day one to five post supretentorial tumour excision. 
To assess the risk factors associated with deranged cerebral autoregulation in supratentorial tumours.  Preoperative day & Postoperative day one to five post supretentorial tumour excision. 
To assess neurological outcome of the patient at 90 days using GOS-E score.  90 days postoperatively 
 
Target Sample Size   Total Sample Size="55"
Sample Size from India="55" 
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   N/A 
Date of First Enrollment (India)   19/08/2025 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This study will begin after obtaining approval from the PGRMC and Institute Ethics Committee (IEC), and registration with the Clinical trials registry of India (CTRI). Standard preanaesthetic evaluation of all participants will be performed. Patients deemed fit for elective surgery and satisfying the inclusion and exclusion criteria will be included in the study after obtaining informed written consent.

Preoperative evaluation and transcranial doppler will be performed on all participants one day before surgery. The evaluation will be done by the primary investigator under the supervision of chief guide. Patient demographics, comorbid illness, glasgow coma score (GCS), medications, and imaging findings including side and location of tumour, midline shift, peri tumoural edema, and mass effect will be noted.

Participants will be explained about transcranial doppler procedure, assured that procedure is non invasive, instructed how to perform breath holding for 30 seconds and hyperventilation. Prior to initiation of TCD, bilateral carotid arteries will be screened for plaques/ stenosis.

The TCD evaluation will be performed for the participants in the Neurosurgical ICU using the (Rimed) transcranial doppler instrument. After positioning the patient supine, non-invasive monitors- NIBP, Pulse oximetry, Etco2 using nasal cannula capnography will be attached and baseline values noted.  Ultrasound coupling gel is applied and A 2MHz TCD probe will be applied over the temporal window after application of liberal amount of gel to insonate the middle cerebral artery (MCA) at a depth of 50-60 mm and is identified by flow towards the doppler probe. Baseline MCA mean flow velocity (V1) will be noted. Baseline heart rate (HR) and mean arterial pressure (MAP), and EtCo2, spo2 will also be recorded at this time point (T0).

Transient hyperemic response test (THRT)

THRT will be done by compressing ipsilateral (to the side of MCA insonation) common carotid artery (CCA) for 10 seconds and looking for changes in MCA mean flow velocity after releasing the compression. (V1) - MCA mean flow velocity before compression of ipsilateral CCA. (V3) - MCA mean flow velocity after release of compression of ipsilateral CCA. Transient hyperemic response ratio (THRR) will be calculated using the formula V3/V1. THRR more than 1.1 will indicate intact autoregulation while less than 1.1 indicate impaired autoregulation. Once MCA flow velocities return to baseline, the test will be repeated, THRR calculated and the average of the 2 readings will be taken for statistical analysis.

Estimation of CO2 reactivity, VMR and CVR.

While MCA velocities return to normal (V1), the patient is asked to continue breathing normally.  Without taking a deep inspiration or sigh, the patient will be asked to hold their breath at the end of expiration and with the lips sealed for a duration of 30 seconds (or until possible). Continuous recording of TCD waveforms will be performed and the mean MCA flow velocity at the end of breath holding (V4) will be noted after which normal breathing will be resumed. Etco2 measurements will be made by attaching nasal cannula capnography to patient and change in Etco2 is noted before and after breath holding/hyperventilation. Then, hyperventilation will be instituted by asking the patient to breathe fast and deep for 30 seconds and mean MCA flow velocity at the end of hyperventilation (V5) will be noted. TCD monitoring will be continued until baseline velocities are reached. The following calculations will be made from the above evaluation:

Absolute CO2 reactivity

Relative CO2 reactivity

Vasomotor reactivity (VMR)

Cerebral vasodilatory reserve (CVR).

The same steps will then repeated on the opposite side and the calculations will be done. All patients will undergo craniotomy for excision of tumour under general anaesthesia. Intraoperative anaesthetic technique will be left to the discretion of the attending anaesthesiologist. Intraoperative details including the anesthetic technique, osmotherapeutic agents used, duration of surgery, fluid and blood transfusion, blood loss, urine output will be noted. Upon dural opening, brain relaxation will be assessed by the operating neurosurgeon and the score noted .Details of complications encountered including brain bulge, venous air embolism, massive blood loss, vasopressor requirement will be recorded. Post-surgery, patients will be extubated on table or will be mechanically ventilated depending on the intraoperative conditions and after discussion with the operating neurosurgeon. THRR will be estimated in intubated patients. Duration of mechanical ventilation, findings of postoperative imaging, and details of postoperative complications (if any) will be noted. Postoperative TCD evaluation of THRR, CO2 reactivity, VMR and CVR will be repeated each day until postoperative day-5. Duration of ICU stay, hospital stay, GCS on discharge and neurological outcome on discharge using GOS-E score will be noted.

GOS-E score at 90 days will be assessed using telephonic interview or during follow-up visits. All data will be recorded on a standard proforma.

 
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