| CTRI Number |
CTRI/2024/07/070071 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Measurement of optic nerve diameter in patients undergoing laparoscopic surgeries |
|
Scientific Title of Study
|
Effect of Optic Nerve Sheath Diameter in Paediatric patients undergoing laparoscopic surgeries |
| 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 Akshay B |
| Designation |
Postgraduate Resident |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology Bangalore Medical College and Research Institute Bangalore. Bangalore Medical College and Research Institute KR Road, Fort,Bangalore-
Mysore
KARNATAKA
570023
India |
| Phone |
7406257088 |
| Fax |
|
| Email |
bakki362@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saraswathi N |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department Of Anaesthesiology Bangalore Medical College and Research Institute Bangalore. Bangalore Medical College and Research Institute KR Road, Fort, Bangalore
Karnataka
560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9663304834 |
| Fax |
|
| Email |
dr.saraswathi.pmssy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saraswathi N |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology Bangalore Medical College and Research Institute Bangalore. Department of Anaesthesiology Bangalore Medical College and Research Institute KR Road, Fort, Bangalore-560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9663304834 |
| Fax |
|
| Email |
dr.saraswathi.pmssy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical College and Research Institute Bangalore KR Road, Fort, Bangalore
Karnataka
560002
India |
|
|
Primary Sponsor
|
| Name |
Bangalore Medical College and Research Institute |
| Address |
Bangalore Medical College and Research Institute, KR Road, Fort Bangalore-560002 |
| 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 Saraswathi N |
Bangalore Medical College and Research Institute |
Department of Anaesthesiology Bangalore Medical College and Research Institute KR Road, Fort,Bangalore-560002
Bangalore
KARNATAKA |
9663304834
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: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I AND Grade II
Children undergoing laparoscopic surgeries |
|
| ExclusionCriteria |
| Details |
Children with a history of allergy to local anesthetic
Children with bleeding disorder
Evidence of peritonitis or septicemia
Presence of hyperthyroidism
Neuritis
Glaucoma
Orbital fracture
Patients refusal
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the impact of ONSD in laparoscopic surgeries during general anaesthesia |
To measure ONSD 15 minutes of pneumoperitoneum and 15 minutes post pneumoperitoneum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Impact on ICP |
To measure ONSD 15 minutes of pneumoperitoneum & 15 minutes post pneumoperitoneum |
|
|
Target Sample Size
|
Total Sample Size="23"
Sample Size from India="23"
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)
|
21/07/2024 |
| 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="0"
Months="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bakki362@gmail.com].
- For how long will this data be available start date provided 01-07-2024 and end date provided 01-08-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
In laparoscopic surgeries carbon dioxide and pneumoperitoneum result in various events such as the potential to increase cerebral blood flow, intracranial pressure and intraocular pressure. Pneumoperitoneum elevates ICP because of the increased abdominal pressure and ICP increases even further in the Trendelenberg position. Pneumoperitoneum also increases cerebral blood flow resulting in an acute rise in ICP that may be harmful to patients with head injury or unrecognized intracranial mass lesion. Direct ICP measurement using a small pressure sensitive probe inserted through the skull is the gold standard for monitoring ICP. For routine surgeries the risks of such an invasive test outweigh the benefits. A new non invasive method the Optic Nerve Sheath Diameter(ONSD) measurement via ultrasonography detects the raised ICP and is reliable and inexpensive and can be repeated many a time. Due to elastic subarachnoid trabecular anatomy, the optic nerve sheath is most distensible at 3mm behind the globe thus making it the best point for ONSD interpretation. ONSD was reported to increase between 15 and 30 mm Hg. Ultrasound based ONSD measurement have been extensively used quickly and non invasively to assess ICP both at clinical and research levels. Hence our study aimed to measure ONSD to assess ICP in paediatric patient |