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CTRI Number  CTRI/2023/08/056679 [Registered on: 21/08/2023] Trial Registered Prospectively
Last Modified On: 19/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   To study the blood flow in the brain during surgery with the help of ultrasound. 
Scientific Title of Study   Comparison of Cerebral Blood Flow During Recovery Between Total Intravenous Anesthesia Versus Balanced Anesthesia Technique in Patients Undergoing Elective Supratentorial Craniotomy: A Randomized 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  Selvendiran P 
Designation  Senior Resident 
Affiliation  Christian Medical College, vellore 
Address  Department of Neuroanaesthesia, Christian Medical College, Vellore.

Vellore
TAMIL NADU
632004
India 
Phone  9566947689  
Fax    
Email  selva224@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Keta Thakkar 
Designation  Associate professor 
Affiliation  Christian Medical College, vellore 
Address  Department of Neuroanaesthesia, Christian Medical College, Vellore.

Vellore
TAMIL NADU
632004
India 
Phone  9879520603  
Fax    
Email  keta0819@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Selvendiran P 
Designation  Senior Resident 
Affiliation  Christian Medical College, vellore 
Address  Department of Neuroanaesthesia, Christian Medical College, Vellore.

Vellore
TAMIL NADU
632004
India 
Phone  9566947689  
Fax    
Email  selva224@gmail.com  
 
Source of Monetary or Material Support  
Christian Medical College, Vellore. 
 
Primary Sponsor  
Name  Christian Medical College Vellore 
Address  Christian Medical College, I da scudder road, Vellore- 632002. Tamilnadu. 
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 
SELVENDIRAN  Christian Medical College  Department of Neuroanaesthesia, CMC Vellore, Ranipet Campus .632002.
Vellore
TAMIL NADU 
9566947689

selva224@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional review board, Christian Medical College, Vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BALANCED ANAESTHESIA  Group B will receive Propofol schnider effect site concentration of 2-3 titrated to a BIS of 40-60 and Fentanyl 1-2 mcg/kg/hr along with Sevoflurane MAC of 0.5. 
Comparator Agent  TIVA ( Total Intravenous Anaesthesia)  Group A will receive infusion of Propofol schnider model effect site concentration of 3-4 titrated to a BIS of 40-60 and Fentanyl 1-2 mcg/kg/hr without volatile anaesthetic agent.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Age 17-65years
2. Supratentorial tumor with no clinical /radiological features of raised ICP-MLS<1 cms
3. ASA 1,2,3
 
 
ExclusionCriteria 
Details  1. Emergency Procedure
2. Severe cardiovascular or respiratory disease (ASA grade ≥3),
3. Poor visulalization of MCA due to inadequate temporal window,
4. Pregnancy,
5. Allergies to Propofol,
6. History of Renal, Liver disease,
7. Psychiatric illnesses,
8. Patient refusal,
9. Awake Craniotomy,
10. GCS<15
11. Preoperative Cognitive defects/Vision Loss
12. Symptomatic Raised Intracranial Pressure with hypertension and Bradycardia
13. Patients on ventilator preoperatively
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of anaesthesia, which is either TIVA with propofol or balanced anesthesia with Sevoflurane on cerebral blood flow by transcranial doppler (TCD) measurement of Mean Flow Velocity (MFV) of middle cerebral artery (MCA) in patients undergoing elective supratentorial craniotomy.  1. baseline before anaesthesia,
2. after intubation
3. postoperatively within 30 minutes after extubation
4. postoperatively within 60 minutes after extubation and
5. on postoperative day 2 - 5 
 
Secondary Outcome  
Outcome  TimePoints 
1. Perioperative measurement of cerebral autoregulation
2. Intra-operative hemodynamic profile
3. Time taken to attain preoperative GCS 
1) Cerebral autoregulation using THRT test in the preoperative period, immediate (60 minutes) & late (3-6 days) postoperative period.
2) Intraoperative Haemodynamic Profile
HR & MAP will be recorded every 15 minutes from the baseline throughout the surgery, at the time of discontinuation (D/C) of IV or volatile agent (VA), at the time of emergence, till 60 minutes after extubation & post-operative between day 2-5.
 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   28/08/2023 
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 Yet Recruiting 
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  

Craniotomies have a higher rate of postoperative complications than the general surgical population and adversely affect the quality of life. Moreover, patients undergoing craniotomy develop postoperative cognitive and physical deficits which makes it difficult to assess the postoperative quality of recovery. With the advances in imaging and surgical techniques, the focus has shifted from merely eliminating pathology to ensuring maximal functional recovery as early as possible. Hence, it is important that anaesthetic techniques in addition to providing favorable intraoperative hemodynamics and brain relaxation must ensure a good quality of recovery to the patient as perceived by the patient. 

It has been hypothesized that different anaesthetic strategies have differential effects on cerebral blood flow (CBF) and metabolic demand (CMRO2). Both propofol and volatile agents reduce CMRO2, and propofol and volatile agents are both systemic vasodilators, although propofol has been shown to reduce CBF, while volatile agents increase CBF. Also, volatile agents impair cerebral autoregulation in a dose-dependent manner, whereas propofol does so to a lesser extent. It is plausible that these divergent cerebrovascular properties have differing effects on the CBF and may impact outcomes in patients undergoing supratentorial craniotomies. We aimed to evaluate the effect of anaesthesia, which is either TIVA with propofol or balanced anaesthesia with Sevoflurane on cerebral blood flow by transcranial doppler (TCD) measurement of Mean Flow Velocity (MFV) of the middle cerebral artery (MCA) in patients undergoing elective supratentorial craniotomy.

 
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