| CTRI Number |
CTRI/2023/06/053616 [Registered on: 07/06/2023] Trial Registered Prospectively |
| Last Modified On: |
09/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Peri-operative changes in Optic Nerve Sheath Diameter in brain tumour patients |
|
Scientific Title of Study
|
Changes in Optic Nerve Sheath Diameter (ONSD), peri-operatively, in patients undergoing elective intracranial tumour resection |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EC/OA-04/2023, protocol version 1.1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHRIKANTA OAK |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
SETH GS MEDICAL COLLEGE & KEM HOSPITAL |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, SETH GS MEDICAL COLLEGE & KEM HOSPITAL, LOWE PAREL, MUMBAI
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820454737 |
| Fax |
|
| Email |
shrikanta_oak@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ARCHANA SHARMA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SETH GS MEDICAL COLLEGE & KEM HOSPITAL |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, SETH GS MEDICAL COLLEGE & KEM HOSPITAL, LOWE PAREL, MUMBAI
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820454737 |
| Fax |
|
| Email |
drarchana7anesthesia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ARCHANA SHARMA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SETH GS MEDICAL COLLEGE & KEM HOSPITAL |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, SETH GS MEDICAL COLLEGE & KEM HOSPITAL, LOWE PAREL, MUMBAI
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820454737 |
| Fax |
|
| Email |
drarchana7anesthesia@gmail.com |
|
|
Source of Monetary or Material Support
|
| NEUROSURGERY OT, SETH GS MEDICAL COLLEGE& KEM HOSPITAL |
|
|
Primary Sponsor
|
| Name |
SETH GS MEDICAL COLLEGE& KEM HOSPITAL |
| Address |
SETH GS MEDICAL COLLEGE& KEM HOSPITAL, LOWER PAREL, MUMBAI |
| 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 |
| ARCHANA SHARMA |
SETH GS MEDICAL COLLEGE& KEM HOSPITAL, LOWER PAREL, MUMBAI |
Neurosurgery OT, 2nd floor, old building
Mumbai
MAHARASHTRA |
9820454737
drarchana7anesthesia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, SETH GSMC &KEMH, MUMBAI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group 18-60 yrs.
2) Both genders
3) BMI< 30kg/m2
4) Undergoing elective intracranial tumour resection surgery |
|
| ExclusionCriteria |
| Details |
1) Pregnant females
2) Glasgow Coma score <8
3) Optic nerve diseases such as optic neuritis, optic nerve arachnoid cyst
4) Any ocular lesion such as orbital mass, orbital injury or prior ocular surgery,
5) Hyperthyroidism |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in optic nerve sheath diameter in the peri-operative period in patients undergoing intracranial tumour resection |
1) prior to surgery
2) immediate post-op
3) 24 hours post-op |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Optic nerve sheath diameter and its correlation with raised ICP based on radiological findings in patients with intracranial tumours |
1) prior to surgery
2) immediate post-op
3) 24 hours post-op |
| Optic nerve sheath diameter and its correlation with raised ICP based on clinical signs and symptoms in patients with intracranial tumours |
1) prior to surgery
2) immediate post-op
3) 24 hours post-op |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
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)
|
19/06/2023 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The optic nerve is enveloped by the optic nerve sheath which surrounds the optic subarachnoid space and is directly linked to the intracranial subarachnoid space. An increase in ICP causes cerebral spinal fluid to move from the intracranial cavity into the optic subarachnoid space, thereby resulting in distension of the optic nerve sheath and widening of its diameter. Therefore, changes in ICP are reflected in the ONSD and measurement of optic nerve sheath diameter (ONSD) by ultrasonography (USG) technique is non-invasive, real-time, portable, easy to perform, cheap and efficient. This study is aimed and designed to estimate the size of ONSD peri-operatively, in patients who undergo intracranial tumour resection, and its correlation with ICP as well as diagnostic accuracy. The aims & objectives are: PRIMARY OBJECTIVE: To assess changes in optic nerve sheath diameter in the peri-operative period in patients undergoing intracranial tumour resection, electively SECONDARY OBJECTIVES: (1) To assess optic nerve sheath diameter and its correlation with raised ICP based on radiological findings in patients with intracranial tumours. (2) To assess optic nerve sheath diameter and its correlation with raised ICP based on clinical signs and symptoms in patients with intracranial tumours. Informed written consent will be obtained from all the included patients prior to the study. The patient’s symptoms will be noted (headache, nausea, vomiting, visual field affection, altered consciousness level suggestive of raised ICP). Intracranial tumour, its size & extent, type, location, and supratentorial/infratentorial location, based on the radiological findings, will be noted. Any features suggestive of raised ICP on CT/MRI (midline shift, cerebral edema, effaced sulci or basal cistern) will also be noted. General anaesthesia will be given to all patients as per institutional protocol. On closed eyelids, the patient’s eyes will be scanned in the supine position using a high-resolution 7-MHz linear array transducer ( Samsung USG machine). The structure of the eyes will be visualized to align with the optic nerve directly opposite the probe kept in sagittal as well as coronal plane over bilateral eyes and the ONSD width will be measured below 3mm below the optic disc. An average of three readings from each eye will be taken for each participant. Transorbital ONSD value 3-4.8 mm will be considered normal (as per available literature) & greater than 4.8 mm will be considered indicative of raised ICP. The duration of surgery use of osmotic agent, if any, will be noted. ONSD measurements will be done at T1, T2, and T3 time points. T1: After induction of anaesthesia but before surgical procedure. T2: At the completion of surgery before extubation. T3: 24 hours post tumour resection. | |
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