| 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
|
|
|
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
|
|
|
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. |