| CTRI Number |
CTRI/2024/09/073599 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
19/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing the Effects of Remote Ischemic Post-Conditioning and a Sham Treatment on Jugular Venous Oxygen Levels and Three-Month Neurological Outcomes in Patients Undergoing Surgery for Intracranial Aneurysms - A Randomized Controlled Trial |
|
Scientific Title of Study
|
Effect of Remote Ischemic Post-Conditioning Vs Sham on Jugular Venous Oximetry and three-month neurological outcomes in patients Undergoing Intracranial Aneurysmal Clipping: A Randomized controlled trial. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nitasha Mishra |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Associate Professor, Department of Anaesthesiology and critical care, All India Institute of Medical Sciences
Sijua, Patrapada, Bhubaneswar, Odisha 751019
Khordha
ORISSA
751019
India |
| Phone |
|
| Fax |
|
| Email |
anaes_nitasha@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya M |
| Designation |
Senior Resident |
| Affiliation |
|
| Address |
Senior Resident, Department of Anaesthesiology and Critical care, All India Institute of Medical Sciences
Sijua, Patrapada, Bhubaneswar, Odisha 751019
Khordha
ORISSA
751019
India |
| Phone |
8861934256 |
| Fax |
|
| Email |
divya.924a@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya M |
| Designation |
Senior Resident |
| Affiliation |
|
| Address |
Senior Resident, Department of Anaesthesiology and critical care, All India Institute of Medical Sciences
Sijua, Patrapada, Bhubaneswar, Odisha 751019
Khordha
ORISSA
751019
India |
| Phone |
8861934256 |
| Fax |
|
| Email |
divya.924a@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,
Sijua, Patrapada, Bhubaneswar, Odisha 751019 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
All India Institute of Medical Sciences,
Sijua, Patrapada, Bhubaneswar, Odisha 751019 |
| 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 Divya M |
All india institute of medical sciences, Bhubaneswar |
Neurosurgery OT, ICU and ward, 4th floor neurosurgery complex.
Khordha
ORISSA |
8861934256
divya.924a@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I607||Nontraumatic subarachnoid hemorrhage from unspecified intracranial artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group R/ True RIPC |
In patients randomised to Group R, blood pressure cuff will be placed in the upper extremity and kept inflated to 30 mmHg above the baseline systolic blood pressure for 5 minutes after which it will be deflated. This technique will be done thrice, over a period of 30minutes. |
| Comparator Agent |
Group S/ Sham RIPC |
In patients randomised to Group S, blood pressure cuff will be placed in the upper extremity and kept inflated to 30 mmHg only, for 5 minutes after which it will be deflated. This technique will be done thrice, over a period of 30minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Consent by the patient or closest of kin
ASA grade I-IV individuals Aged 18-65years, scheduled for surgical clipping of the ruptured aneurysm during the study period
Patients presenting up to 7 days of ictus.
Modified Hunt and Hess Grade 1 to 3
|
|
| ExclusionCriteria |
| Details |
Patients not willing to give consent
Hunt and Hess Grade more than 3
Patients requiring inotropic support preoperatively
DVT and history of peripheral vascular disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of RIPC on Cerebral Oxygenation as measured on jugular venous catheter (SjvO2) at 24hours after aneurysm clipping |
24hours after aneurysm clipping |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of cerebral deoxygenation in the two group within 7 days after surgery. |
7 days |
| Days spent in Vasospasm diagnosed by TCD between groups |
7 days post op or until discharge from ICU |
| Quantitative Troponin I level at 48hrs in between groups. |
48hrs after aneurysm clipping |
| CT-Angiography and Perfusion CT on POD 7 to assess mean transit time (MTT), cerebral blood flow (CBF) and cerebral blood volume (CBV). |
post op day 7 |
| GOSE and Modified Rankin Scales |
at discharge and 3months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/09/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This randomized controlled trial is aimed to study the effects of remote ischemic post-conditioning (RIC) versus a sham procedure on jugular venous oximetry and three-month neurological outcomes in patients undergoing intracranial aneurysmal clipping. Aneurysmal subarachnoid hemorrhage (aSAH), caused by ruptured intracranial aneurysms, is a significant global health issue with high morbidity and mortality rates. Cerebral vasospasm and delayed cerebral ischemia (DCI) are common complications of aSAH, contributing to poor outcomes. Remote ischemic conditioning (RIC), which involves inducing brief periods of ischemia, has shown promise in reducing ischemia-reperfusion injury in various organs, including the brain. Previous studies have explored RIC in different contexts, such as pre-procedural RIC, early postconditioning, and chronic postconditioning, with some showing beneficial effects in cerebrovascular diseases and post-aneurysm repair surgery. While RIC has been investigated for its potential to mitigate cerebral vasospasm and improve outcomes after aSAH, there is a lack of research on its impact on jugular venous oximetry during aneurysmal clipping procedures. This study aims to address this gap by evaluating whether RIC can improve cerebral oxygenation and neurological outcomes in this patient population, hypothesizing that RIC may protect against cerebral vasospasm and ischemic injury, leading to better cerebral oxygenation and improved neurological recovery. |