| CTRI Number |
CTRI/2019/08/020692 [Registered on: 13/08/2019] Trial Registered Prospectively |
| Last Modified On: |
09/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
LONGITUDINAL |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
EFFECT OF SURGERY ON BLOOD FLOW TO BRAIN IN MOYAMOYA DISEASE |
|
Scientific Title of Study
|
CHANGES IN REGIONAL CEREBRAL OXYGEN SATURATION FOLLOWING SURGICAL REVASCULARISATION IN MOYAMOYA DISEASE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
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|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JAYANTH R SESHAN |
| Designation |
SENIOR RESIDENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI |
| Address |
DEPARTMENT OF NEUROANAESTHESIA, C.N CENTRE., ALL INDIA INSTITUTE OF MEDICAL SCIENCES,
South
DELHI
110029
India |
| Phone |
8424017925 |
| Fax |
|
| Email |
drrjayanth.seshan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR GIRIJA PRASAD RATH |
| Designation |
PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI |
| Address |
DEPARTMENT OF NEUROANAESTHESIA, C.N. CENTRE., ALL INDIA INSTITITE OF MEDICAL SCIENCES
South
DELHI
110029
India |
| Phone |
9810602272 |
| Fax |
|
| Email |
girijarath@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
JAYANTH R SESHAN |
| Designation |
SENIOR RESIDENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI |
| Address |
DEPARTMENT OF NEUROANAESTHESIA, C.N. CENTRE., ALL INDIA INSTITUTE OF MEDICAL SCIENCES
South
DELHI
110029
India |
| Phone |
8424017925 |
| Fax |
|
| Email |
drrjayanth.seshan@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF NEUROANAESTHESIA, AIIMS NEW DELHI |
|
|
Primary Sponsor
|
| Name |
DEPT OF NEUROANAESTHESIA AIIMS |
| Address |
DEPARTMENT OF NEUROANAESTHESIA, 6TH FLOOE, C.N.CENTRE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI 110029 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR JAYANTH R SESHAN |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
NEUROSURGERY OPERATION THEATRE AND NEUROSURGERY ICU, C.N CENTRE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI
South
DELHI |
8424017925
drrjayanth.seshan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITURE ETHICS COMMITTEE, AIIMS, NEW DELHI |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I675||Moyamoya disease, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients with angiographically diagnosed Moyamoya disease and posted for revascularisation are to be included in the study. |
|
| ExclusionCriteria |
| Details |
1. Refusal of consent
2. Moyamoya syndrome – associated with other vascular lesions of the brain, CNS
tumours, prior history of radiation for CNS tumours, Down’s syndrome.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the changes in regional cerebral oxygen saturation (rSO2) following surgical revascularisation in patients with Moyamoya Disease. |
Till 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the postoperative changes in rSO2 observed following different surgical methods and anaesthetic techniques used |
24 hours after surgery |
| To assess the utility of rSO2 as a predictor of postoperative complications after revascularisation procedures |
24 hours after surgery |
| To assess long term clinical outcomes in revascularisation procedures using modified Rankin score |
90 days after surgery |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
15/08/2019 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
NIRS
aids in non-invasive and continuous monitoring of regional cerebral oxygen
saturation and will guide in assessing the changes in cerebral blood flow in
the postoperative period following revascularisation surgeries in Moyamoya
disease. Feasibility issues concerning other conventional postoperative
neuroimaging modalities can be partially overcome using this continuous
monitoring technique. |