| CTRI Number |
CTRI/2023/07/054635 [Registered on: 03/07/2023] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of impact of use of inhalational and intravenous anaesthetic drugs on the outcome of aneurysmal clipping surgery. |
|
Scientific Title of Study
|
Effect of intravenous anaesthetics versus inhalational anaesthetics on delayed cerebral ischemia following aneurysmal sah: a randomised clinical trial (IVIA-DAS) |
| Trial Acronym |
IVIA-DAS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hemant Bhagat |
| Designation |
Professor |
| Affiliation |
Postgraduate institute of medical education and research, chandigarh |
| Address |
Room no 26, Offices, second floor, Nehru Hospital, Postgraduate Institute of Medical Education and Research, Chandigarh
Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9216387387 |
| Fax |
|
| Email |
hembhagat@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemant Bhagat |
| Designation |
Professor |
| Affiliation |
Postgraduate institute of medical education and research, chandigarh |
| Address |
Room no 26, Offices, second floor, Nehru Hospital, Postgraduate Institute of Medical Education and Research, Chandigarh
Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9216387387 |
| Fax |
|
| Email |
hembhagat@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemant Bhagat |
| Designation |
Professor |
| Affiliation |
Postgraduate institute of medical education and research, chandigarh |
| Address |
Room no 26, Offices, second floor, Nehru Hospital, Postgraduate Institute of Medical Education and Research, Chandigarh
Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9216387387 |
| Fax |
|
| Email |
hembhagat@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research |
| Address |
Sector 12, Chandigarh, 160036, India |
| 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 Prudhvi Raj Veparala |
Postgraduate Institute of Medical Education and Research |
Main Operation Theatre, 5 floor, A block, Department of Anaesthesia and Intensive Care
Chandigarh
CHANDIGARH |
9500918238
Prudhviofficialmail@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Propofol |
Dose: 25 - 100 mcg/kg/min
Route: intravenous
Frequency: entire duration of surgery( approximately 2-3 hours)
|
| Comparator Agent |
Sevoflurane |
Dose : 1- 2% v/v in gaseous form
Route: inhalational
Frequency: Entire duration of surgery( approximately 2-3 hours) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Ruptured aneurysm posted for Surgical Clipping
WFNS grade 1,2,3
Anterior circulation aneurysm |
|
| ExclusionCriteria |
| Details |
Postictal day 4 or more
Postoperative neurological deterioration due to surgical or systemic causes
Hydrocephalus
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the incidence of delayed cerebral ischemia in patients undergoing
clipping of aneurysm surgery under general anesthesia with sevoflurane when compared
to propofol. |
starting after the surgery till the discharge from hospital |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Estimation of CSF eNOS levels |
intraoperative ( during aneurysm Clipping surgery) |
| Neurological outcome at discharge ( MRS score) |
at discharge |
| Neurological outcome at 3 months post surgery(GOSE, MRS score) |
1 months after surgery, 3 months after surgery |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
13/07/2023 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
This trial is designed to see the effect of anaesthesia drugs on the incidence of delayed cerebral ischemia in patients of aneurysmal subarachnoid haemorrhage undergoing surgical clipping of the neck of aneurysm. after randomly dividing into two groups, patients of one group will receive propofol( intravenous) as an anaesthetic agent, while the other will receive sevoflurane ( inhalational) as the anaesthetic agent. Postoperatively these patients are followed up to compare the incidence of Delayed cerebral ischemia between the two groups. Secondarily we reach CSF levels of the eNOS enzyme, collected at the time of surgery. we also check neurological outcomes using MRS scoring at discharge and both MRS and GOSE scale at 1 month and w3 months.w |