| CTRI Number |
CTRI/2025/04/085717 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of carbon dioxide on blood supply of brain when using two anaesthesia agents in new born babies undergoing surgery and using ultrasound to look at the change in blood flow to the brain |
|
Scientific Title of Study
|
Comparison of cerebro vascular reactivity to carbon dioxide at equi MAC doses of Isoflurane and sevoflurane in neonates (Varis study): A randomised controlled study |
| Trial Acronym |
VARIS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anudeep Jafra |
| Designation |
additional Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
4th floor, B block, Department of anaesthesia and Intensive care, Nehru Hospital, sector 12, Chandigarh
4th floor, B block, Department of anaesthesia and Intensive care, Nehru Hospital, sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888027699 |
| Fax |
|
| Email |
anu_gmch@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Preethy J Mathew |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
4th floor, B block, Nehru Hospital, Department of Anaesthesia and Intensive care, Post Graduate Institute of Medical Education and Research
4th floor, B block, Nehru Hospital, Department of Anaesthesia and Intensive care, Post Graduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9417800203 |
| Fax |
|
| Email |
tjpreethy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anudeep Jafra |
| Designation |
additional Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
4th floor, B block, Nehru Hospital, Department of anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research
4th floor, B block, Nehru Hospital, Department of anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888027699 |
| Fax |
|
| Email |
anu_gmch@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| 4th floor, B block, Nehru Hospital, Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, sector-12, Chandigarh, India, 160012 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research, sector 12, Chandigarh |
| Address |
4th floor, B block, Department of Anaesthesia, Post Graduate Institute of Medical Education and Research, sector 12, Chandigarh, 160012 |
| 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 |
| Dr Anudeep Jafra |
Post Graduate Institute of Medical Education and Research, Chandigarh, sector 12 |
Post Graduate Institute of Medical Education and Research, Chandigarh, sector 12, Operation theatre complex, 6th floor, Advanced Pediatric centre
Chandigarh
CHANDIGARH |
9888027699
anu_gmch@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute of Medical Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: P84||Other problems with newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
trans cranial colour coded duplex ultrasonography |
ultrasound will be done at two points when end tidal CO2 is 35 mmHg and 45mmHg, at each end tidal value three readings will be taken and average will be calculated. trans cranial colour coded duplex ultrasonography would be done in neonates after receiving general anaesthesia at 0.8 MAC of anaesthetic agent isoflurane/ sevoflurane. ultrasound would be done with2 -4 MHZ probe, keeping probe over the left temporal window of the skull just cephalad to the zygomatic arch and approximately 2cm in front of the tragus, at end tidal carbon dioxide 35mmHg . the flow velocity of middle cerebral artery would be calculated. |
| Comparator Agent |
trans cranial colour coded duplex ultrasonography |
ultrasound will be done at two points when end tidal CO2 is 35 mmHg and 45mmHg, at each end tidal value three readings will be taken and average will be calculated. trans cranial colour coded duplex ultrasonography would be done in neonates after receiving general anaesthesia at 0.8 MAC of anaesthetic agent isoflurane/ sevoflurane. ultrasound would be done with2 -4 MHZ probe, keeping probe over the left temporal window of the skull just cephalad to the zygomatic arch and approximately 2cm in front of the tragus, at end tidal carbon dioxide 45mmHg . the flow velocity of middle cerebral artery would be calculated. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Term neonates
Scheduled for non Intrathoracic and non neurosurgical procedures under anaesthesia |
|
| ExclusionCriteria |
| Details |
Hemodynamically unstable and on inotropes
Congenital heart disease
Heart failure or respiratory disorders
Preterm neonates
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in mean flow velocity of the distal MCA (M1 segment) with the change in EtCO2 from 35mmHg to 45mmHg |
15 minutes and 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in systolic flow velocity of the distal MCA (M1 segment) with change in EtCO2 from 35 mmHg to 45 mmHg
2. Change in diastolic flow velocity of the distal MCA (M1 segment) with change in EtCO2 from 35 mmHg to 45 mmHg
3. Absolute CCO2R reactivity
4. Resistive index (RI)
5. Pulsatility index (PI)
6. Complications due to the procedure- pressure effects at temporal site, hemodynamic instability due to intervention (rescue therapy used- fluid bolus/vasopressor)
|
15 minutes, 30 minutes |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
09/05/2025 |
| 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="1"
Months="6"
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
|
Inhaled anaesthetics increase the Cerebral Blood Flow and affects cerebrovascular reactivity to CO2, largely maintained till 1 minimum alveolar concentration (MAC). The cerebral vasodilatory effects of inhaled anaesthetic agents are far more pronounced in children as compared to adult population. Sevoflurane and Isoflurane do not have similar effects on cerebral circulation. Sevoflurane is a less potent cerebral vasodilator and preserves the dynamic Cerebral Autoregulation as compared to isoflurane when administered in equal MAC doses. Study in adults have suggested that Isoflurane preserves the cerebro vascular reactivity to carbon dioxide upto 1 MAC, whereas sevoflurane has been shown not to have effect within a range of 0.5-1 MAC. However, there is no data on effect of anaesthetic agents on cerebro vascular reactivity to carbon dioxide in neonates. We hypothesized that sevoflurane would preserve the cerebro vascular reactivity to carbon dioxide better than isoflurane in neonates undergoing non cardiac surgery under GA at equal MAC doses when the End Tidal carbon dioxide (EtCO2) changes from 35 mmHg to 45 mmHg.
|