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CTRI Number  CTRI/2023/06/053987 [Registered on: 16/06/2023] Trial Registered Prospectively
Last Modified On: 15/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia
Diagnostic 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Which Volatile Anesthetic agent causes more increase in blood flow to brain during Brain Tumor Surgery 
Scientific Title of Study   Comparison of cerebral vasodilatory effects of sevoflurane, isoflurane & desflurane in patients undergoing surgery for supratentorial lesions under general anesthesia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mayank Arora 
Designation  DM Resident  
Affiliation  National institute of mental health and neurosciences 
Address  Department of Neuroanesthesia and Neurocritical Care, third floor, Faculty block, NIMHANS, Hosur road

Bangalore
KARNATAKA
560029
India 
Phone  8800778137  
Fax    
Email  maestromayank196@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sudhir Venkataramaiah 
Designation  Additional Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Neuroanesthesia and Neurocritical Care, third floor, Faculty block, NIMHANS, Hosur road

Bangalore
KARNATAKA
560029
India 
Phone  9900793108  
Fax    
Email  vsudhir77@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sudhir Venkataramaiah 
Designation  Additional Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Neuroanesthesia and Neurocritical Care, third floor, Faculty block, NIMHANS, Hosur road

Bangalore
KARNATAKA
560029
India 
Phone  9900793108  
Fax    
Email  vsudhir77@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Mental Health and Neurosciences, Bangalore 
 
Primary Sponsor  
Name  National Institute of Mental Health and Neurosciences 
Address  Hosur road, Bangalore, PIN 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 
Mayank Arora  National Institute of Mental Health and Neurosciences   Department of Neuroanesthesia and Neurocritical Care, third floor, Faculty block, NIMHANS, Hosur road
Bangalore
KARNATAKA 
08800778137

maestromayank196@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of SDS TRC and RGICD SDS TRC and RGICD  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D330||Benign neoplasm of brain, supratentorial, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Desflurane  Volatile Anesthetic Agent 
Comparator Agent  Isoflurane  Volatile Anesthetic agent 
Intervention  Near-Infrared Spectroscopy  Near-Infrared Spectroscopy will be used to measure Changes in Cerebral Oxygen Saturation during Induction of Anesthesia till MAC 1 is achieved. All recordings will be done bilaterally as "Tumour side" and "Normal side" Measurements 
Comparator Agent  Sevoflurane  Volatile Anesthetic Agent 
Intervention  Transcranial Doppler  Transcranial Doppler will be used to measure Change in Blood flow Velocity in Middle Cerebral Artery and Pulsatility Index during Induction of Anesthesia till MAC 1 is achieved. Measurements will be recorded bilaterally as "Tumour side" and "Normal side" Measurements 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Unilateral Supratentorial Lesion
ASA Physical Grade 1 and 2 
 
ExclusionCriteria 
Details  Refusal of Consent
Patients with Poor Acoustic Window
Hemodynamically unstable patient requiring inotropic infusion
Plaques/Stenosis observed on Carotid Artery Doppler in the preoperative period the day before surgery 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare Change in Mean Blood Flow Velocity in Middle Cerebral Artery among the 3 Volatile anesthetics  Baseline to 1 MAC 
 
Secondary Outcome  
Outcome  TimePoints 
To compare Pulsatility Index among the 3 Volatile Anesthetics  1 MAC 
To compare Regional Oxygen Saturation (rS02) among the 3 Volatile Anesthetics  1 MAC 
To compare the effects of 1 MAC of Isoflurane Sevoflurane & Desflurane on Middle Cerebral Artery Flow Velocities between the cerebral hemisphere with tumor and normal side  1 MAC 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   25/06/2023 
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="1"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Volatile anesthetics have a dual effect on cerebral vasculature. In low concentrations, they constrict cerebral vessels secondary to suppression of metabolism. With increasing concentration, the direct vasodilatory effect of volatile anesthetics turns dominant, leading to increased cerebral blood flow and brain volume. An increase in Cerebral blood volume will result in an increase in brain bulk in absence of autoregulation and eventually makes surgical access difficult.

Transcranial Doppler (TCD) provides an indirect measure of CBF by measuring blood flow velocity in Middle Cerebral artery, if the angle of insonation and vessel diameter remain constant. Although Middle Cerebral artery (MCA) flow velocity does not reflect absolute Cerebral Blood flow (CBF), change in MCA flow velocity is directly proportional to change in CBF.

Pulsatility index (PI) is defined as the difference between the peak systolic flow and minimum diastolic flow velocity, divided by the mean velocity recorded throughout the cardiac cycle. It is a non-invasive method of assessing vascular resistance in major blood vessels with the use of Doppler ultrasonography. PI >1.5 in Middle Cerebral artery using Transcranial Doppler has been shown to be an indicator of increased Intracranial Pressure.

NIRS is a non-invasive monitor, well suited for repeated measurement of cerebral oxygen saturation changes. It has been used to monitor cerebral autoregulation, based on the assumption that the brain’s oxygen content is positively related to cerebral blood flow.

Isoflurane is a widely used volatile anesthetic in neurosurgical procedures and has been shown to cause cerebral vasodilatation, especially at concentrations required to induce deep plane of anesthesia.

 Sevoflurane, a newer volatile anesthetic agent, is very similar to isoflurane in its cardiovascular effects. Although sevoflurane has been shown to have similar cerebral vascular effects to isoflurane in animals, this has not been a consistent finding in humans.

Desflurane, a more recently introduced volatile anesthetic agent, has been shown to induce more cerebral vasodilatation than sevoflurane and isoflurane in animals. In humans, cerebral vascular properties of desflurane are similar to that of isoflurane.

Cerebral autoregulation has been observed to be impaired in patients with large supratentorial lesion and midline shift more than 5 mm.

 There has been paucity of literature on comparison of cerebral vasodilatory properties of isoflurane, sevoflurane and desflurane. There is also sparse literature on the cerebrovascular effects of volatile anesthetic agents in supratentorial lesions. To fill this knowledge gap, we propose a comparative study of cerebral vasodilatory effects of isoflurane, sevoflurane, and desflurane.

We hypothesize that Cerebral Vasodilatory Effects of Sevoflurane, Isoflurane and Desflurane are comparable in patients undergoing surgery for supratentorial lesions under surgical depth of anesthesia.

 
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