| 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
|
|
|
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
|
|
|
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. |