| CTRI Number |
CTRI/2020/12/029996 [Registered on: 23/12/2020] Trial Registered Prospectively |
| Last Modified On: |
18/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Intracranial pressure monitoring by optic nerve measurement in operation teatre |
|
Scientific Title of Study
|
Ultrasound guided measurement of optic nerve sheath diameter as a measure of ICP monitoring in patients undergoing craniotomy under General anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinay Marulasidappa |
| Designation |
Professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Anaesthesia department,Pmssy bmcri.bangalore
Pmssy bmcri.bangalore
Bangalore
KARNATAKA
56001
India |
| Phone |
09663304834 |
| Fax |
|
| Email |
drvinaym@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saraswathi Nagapaa |
| Designation |
Assistant professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Anaesthesia department,Pmssy bmcri.bangalore
Pmssy bmcri.bangalore
Bangalore
KARNATAKA
56001
India |
| Phone |
09663304834 |
| Fax |
|
| Email |
dr.saraswathi.pmssy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarawathi N |
| Designation |
Assistant professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Anaesthesia department,Pmssy bmcri.bangalore
Pmssy bmcri.bangalore
Bangalore
KARNATAKA
56001
India |
| Phone |
09663304834 |
| Fax |
|
| Email |
dr.saraswathi.pmssy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anaesthesia department super speciality hospital (PMSSY) ,Bangalore medical college,Bangalore |
|
|
Primary Sponsor
|
| Name |
Anaesthesia departmentfifth floorsuper speciality hospital |
| Address |
Bangalore medical college and research institute,K R road ,bangalore |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Saraswathi N |
Anaesthesia department,pmssy,bmcri,Bangalore |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saraswathi N |
Super speciality hospital (PMSSY) |
Anesthesia department,fifth floor,super specialty hospital (PMSSY), Victoria campus,KR road, Bangalore medical college and research institute
Bangalore
KARNATAKA |
09663304834
dr.saraswathi.pmssy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore medical college and research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G932||Benign intracranial hypertension, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient with intracranial space occupying lesions undergoing craniotomy |
|
| ExclusionCriteria |
| Details |
Optic nerve tumor
Neuritis
Glaucoma
Orbital fracture |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the validity of optic nerve sheath diameter measured ultrasonography with standard radiological investigation for raised Intracranial pressure under general anesthesia |
Optic nerve sheath diameter during before and after intubation and before ,before and after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of intubation and extubation on intracranial pressure |
During intubation and extubation under general anesthesia |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
28/12/2020 |
| 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
|
Nt yt |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective study we aimed to investigate demographic measurement of the optic nerve sheath diameter as a method for detecting raised ICP in patients undergoing craniotomy. The present study was planned for the patients with intracranial space occupying lesions undergoing craniotomy under general anesthesia,to assess its validity. |