| CTRI Number |
CTRI/2024/11/077510 [Registered on: 29/11/2024] Trial Registered Prospectively |
| Last Modified On: |
29/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Anaesthetic gas Sevoflurane on blood vessel following aneurysmal subarachnoid hemorrhage, in patients receiving nimodipine, assessed by radiology imaging :a prospective randomized controlled trial |
|
Scientific Title of Study
|
Effect of Sevoflurane on vasospastic cerebral vasculature following aneurysmal sah, in patients receiving intra- arterial nimodipine, assessed by digital subtraction angiography :a prospective randomized controlled trial(SIAN-VCV trial) |
| Trial Acronym |
SIAN-VCV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sk Ahadul Islam |
| Designation |
SR neuroanaesthesia |
| Affiliation |
Post Graduate Institute of medical education and research |
| Address |
Anaesthesia and intensive care,Post Graduate Institute of medical education and research,neheru hospital,chandigarh,sector 12
Chandigarh
CHANDIGARH
160012
Other |
| Phone |
9903249642 |
| Fax |
|
| Email |
dr.islamahadul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nidhi Bidyut Panda |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of medical education and research |
| Address |
Anaesthesia and intensive care,Post Graduate Institute of medical education and research,neheru hospital,chandigarh,sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009525 |
| Fax |
|
| Email |
nidhibp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sk Ahadul Islam |
| Designation |
SR neuroanaesthesia |
| Affiliation |
Post Graduate Institute of medical education and research |
| Address |
Anaesthesia and intensive care,Post Graduate Institute of medical education and research,neheru hospital,chandigarh,sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9903249642 |
| Fax |
|
| Email |
dr.islamahadul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Thesis Grant By Post Graduate Institute of Medical Education and Research, Chandigarh , India , PIN 160012 |
|
|
Primary Sponsor
|
| Name |
Director PGIMER |
| Address |
Post Graduate Institute of medical education and research,Nehru hospital,chandigarh,sector 12, Chandigarh , India pin 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 SK AHADUL ISLAM |
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH |
DEPT OF ANAESTHESIA AND INTENSIVE CARE , 4TH FLOOR NEHRU HOSPITAL, SECTOR 12, CHANDIGARH,160012
Chandigarh
CHANDIGARH |
9903249642
dr.islamahadul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate institute of medical education and research chandigarh institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, (2) ICD-10 Condition: D80-D89||Certain disorders involving the immune mechanism, (3) ICD-10 Condition: G973||Intraoperative hemorrhage and hematoma of a nervous system organ or structure complicating a procedure, (4) ICD-10 Condition: G973||Intraoperative hemorrhage and hematoma of a nervous system organ or structure complicating a procedure, (5) ICD-10 Condition: G978||Other intraoperative and postprocedural complications and disorders of nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
propofol |
propofol dose of induction 1-2 mg/kg followed by maintenance dose 50-200 microgram/kg/min as intravenous infusion till the procedure end on the basis of target entropy 40-60. |
| Intervention |
Sevoflurane |
Sevoflurane will be used in dose of 1- 1.3 MAC for induction and upto procedure completed. Effect on diameter of measure cerebral vessel will be noted by digital subtraction angiography. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adults patients (age 18 yrs) with cerebral vasospasm following aneurysmal subarachnoid hemorrhage posted for intra-arterial nimodipine who are either unconscious,semiconscious,irritable or intubated and need for general anaesthesia for the procedure |
|
| ExclusionCriteria |
| Details |
1. Patient or legal heir’s refusal for consent
2. Patient with H/O allergy to test drugs
3. Patient who received intraarterial Nimodipine previously.
4. Patients having deranged renal parameters
5. Patients with vasculitis.
6. Patient having hydrocephalus.
7. Patients having abnormal coagulation parameters
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect on diameter of major cerebral vessels ICA,MCA,ACA |
Baseline before giving general anesthesia and after nimodipine administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess changes in Cerebral Arterio-Venous Transit Time which is a surrogate marker of the cerebral blood flow by DSA.
2. Cerebral blood flow velocity (SFV/DFV/MFV), Pulsatility Index (PI) and Lindegaard ratio measured by TCD, before the procedure, 1 hour and 24 hours after procedure. These parameters will be measured once daily again for 1-5 days after IA Nimodipine.
3. Total dose of intra-procedure nimodipine.
4. Requirement of additional doses of Intra-arterial nimodipine during ICU stay.
5. Development of cerebral infarction during ICU stay.
6. Neurological status of the patients at discharge by Modified Rankin score (mRS).
|
0 Days till discharge |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
11/12/2024 |
| 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
|
subarachnoid hemorrhage following rupture of cerebral aneurysm is a life-threatening condition. Who survive many of them suffer from severe neurological and neurocognitive deficits. One of the most dangerous consequences of aneurysmal subarachnoid hemorrhage is cerebral vasospasm described as reversible constriction of cerebral blood vessels, mostly affecting major vessels of circle of Willis . The effectiveness of oral and intra-arterial nimodipine in preventing and treating cerebral vasospasm and decreasing cerebral infraction is well established. Sevoflurane is a cerebral vasodilator. Digital subtraction angiography is a method by which direct vessel can be measured using electronic caliper. Previous study showed that effects of propofol and sevoflurane on cerebral vasculature in patients with aneurysmal subarachnoid hemorrhage using digital subtraction angiography and observed that sevoflurane has vasodilating properties compared to propofol in patients with aneurysmal subarachnoid hemorrhage Hypothesis is that sevoflurane has synergistic effect of vasodilation with that of intra-arterial nimodipine in patients with cerebral vasospasm following aneurysmal subarachnoid hemorrhage. The mean change in vascular diameter from baseline during nimodipine therapy will be greater under sevoflurane anesthesia than under propofol based anesthesia in patients presenting for intra-arterial nimodipine therapy for vasospasm following aneurysmal subarachnoid hemorrhage. |