| CTRI Number |
CTRI/2025/02/080663 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to evaluate and compare the brain oxygen levels using Near Infrared Spectroscopy during and after surgery in patients undergoing endovascular coiling or surgical clipping of brain aneurysm. |
|
Scientific Title of Study
|
Study to evaluate and compare the regional cerebral oxygenation levels using Near Infrared Spectroscopy during perioperative period in patients undergoing endovascular coiling or surgical clipping of intracranial aneurysm. |
| 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 Nupur Khewle |
| Designation |
DM Neuroanaesthesia resident |
| Affiliation |
GIPMER |
| Address |
Department of Anaesthesiology and Intensive care, 6th floor, Academic block,
GIPMER, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
6265572234 |
| Fax |
|
| Email |
dr.nupurkhewle@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Khurana |
| Designation |
Professor, Neuroanaesthesia Unit |
| Affiliation |
GIPMER |
| Address |
Department of Anaesthesiology and Intensive care, 6th floor, Academic block,
GIPMER, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9718592495 |
| Fax |
|
| Email |
dr_priyankamadan@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Khurana |
| Designation |
Professor, Neuroanaesthesia Unit |
| Affiliation |
GIPMER |
| Address |
Department of Anaesthesiology and Intensive care, 6th floor, Academic block,
GIPMER, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9718592495 |
| Fax |
|
| Email |
dr_priyankamadan@hotmail.com |
|
|
Source of Monetary or Material Support
|
| GB Pant Institute of Postgraduate Medical Education and Research, New Delhi, India, 110002 |
|
|
Primary Sponsor
|
| Name |
GB Pant Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anaesthesiology and Intensive care, 6th floor, Academic block, GIPMER, New Delhi, India, 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Nupur Khewle |
GB Pant Institute of Postgraduate Medical Education and Research |
Department of Anaesthesiology and Intensive care, 6th floor, Academic block, New Delhi, India, 110002
New Delhi
DELHI |
6265572234
dr.nupurkhewle@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College and associated hospitals |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NOT APPLICABLE |
NOT APPLICABLE |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with aneurysmal subarachnoid hemorrhage of anterior circulation posted for endovascular coiling or surgical clipping. |
|
| ExclusionCriteria |
| Details |
Patients with with posterior circulation aneurysm, ASA physical status V and VI, Pre-existing chronic neurologic disease, Moderate and severe systolic dysfunction (Ejection fraction less than 40%), Severe valvular stenosis (aortic or mitral), Unoptimized circulatory shock, Severe anaemia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Regional cerebral oxygenation levels during intraoperative and initial postoperative period for six hours in patients undergoing endovascular coiling or surgical clipping |
Baseline values before administration of any drug
Every 5minutes till the patient is either extubated or shifted out of operation theatre intubated
Every 15 minutes till 6 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Area under curve of regional cerebral oxygenation levels below 10% from baseline |
Baseline values before administration of any drug
Every 5minutes till the patient is either extubated or shifted out of operation theatre intubated
Every 15 minutes till 6 hours postoperatively |
Correlation of regional cerebral oxygenation levels with-
the occurrence of delayed cerebral ischemia
the grade of modified Rankin Scale
number of days on mechanical ventilation
number of days in ICU |
Up to 30 days of postoperative period |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/02/2025 |
| 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="0"
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
|
Aneurysmal subarachnoid
hemorrhage (aSAH) after rupture of an intracranial aneurysm may lead to
cerebral hypoxia which can have profound
adverse outcomes like stroke, focal neurological impairment, delayed cerebral
ischemia, and prolonged neuro-intensive care unit and hospital
stays. As cerebral hypoxia can
potentially develop during aneurysm clipping and coiling, monitoring
of cerebral oxygen levels are thus essential for early detection and timely management of cerebral
hypoxia to enable improved outcomes in aSAH patients. We aim to compare the
regional cerebral oxygenation (rSO2) levels using Near Infrared Spectroscopy
(NIRS) during peri-operative period in patients undergoing endovascular coiling
or surgical clipping of intracranial aneurysm and to correlate its impact on
postoperative neurological outcome. To treat a critical reduction in cerebral
oximetry values (these interventions will be done only when rSO2 level achieves
a critical threshold (rSO2<20% from baseline) oxygen delivery and oxygen consumption will be optimized. |