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CTRI Number  CTRI/2020/01/022860 [Registered on: 20/01/2020] Trial Registered Prospectively
Last Modified On: 16/01/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to assess changes in Optic Nerve Sheath Diameter during Neurosurgery  
Scientific Title of Study   Perioperative variation in Optic Nerve Sheath Diameter measured by Transbulbar Ultrasonography in Neurological patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Varun S 
Designation  Assistant Professor 
Affiliation  Government Medical College Thiruvananthapuram 
Address  Department of Anaesthesiology Government Medical College Thiruvananthapuram

Thiruvananthapuram
KERALA
695011
India 
Phone    
Fax    
Email  varunsureshpgi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Varun S 
Designation  Assistant Professor 
Affiliation  Government Medical College Thiruvananthapuram 
Address  Department of Anaesthesiology Government Medical College Thiruvananthapuram


KERALA
695011
India 
Phone    
Fax    
Email  varunsureshpgi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Varun S 
Designation  Assistant Professor 
Affiliation  Government Medical College Thiruvananthapuram 
Address  Department of Anaesthesiology Government Medical College Thiruvananthapuram


KERALA
695011
India 
Phone    
Fax    
Email  varunsureshpgi@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College Thiruvananthapuram 
 
Primary Sponsor  
Name  Dr Varun S 
Address  Assistant Professor Department of Anaesthesiology Government Medical College Thiruvananthapuram 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Varun S  Department of Anaesthesiology  Government Medical College Thiruvananthapuram
Thiruvananthapuram
KERALA 
9041426743

varunsureshpgi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HUMAN ETHICS COMMITTEE, Government Medical College Thiruvananthapuram  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S065||Traumatic subdural hemorrhage,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult patients with traumatic brain injury 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Perioperative variation in optic nerve sheath measured by Ultrasonography  Optic nerve sheath diameter will be measured twice.
1. After induction of general anaesthesia and before surgery.
2. After surgery with the patient still under general anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   20/01/2020 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   1. Kim JY, Min HG, Ha SI, Jeong HW, Seo H, Kim JU. Dynamic optic nerve sheath diameter responses to short-term hyperventilation measured with sonography in patients under general anesthesia. Korean J Anesthesiol. 2014; 67(4): 240-5. 2. Kim SH, Kim HJ, Jung KT. Position does not affect the optic nerve sheath diameter during laparoscopy. Korean J Anesthesiol. 2015; 68(4): 358-63.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Achieving optimum intracranial pressure is a core concept in neurosurgical disease. Transbulbar sonography is yet to gain wide application in surgeries for primary neurosurgical disease. Transbulbar sonography if well validated in this group of patients can sooner or later replace or corroborate other methods of intracranial pressure measurement. In this context the impact of intracranial procedures on measurements of optic nerve sheath by sonograpy pre and post-operatively attains relevance. 

As transbulbar ONSD measurement by sonography is gaining much impetus, the fallacies of this technique, if any, in primary neurosurgical disease need to be clearly defined. Till date no studies have compared the application of transbular sonography in primary neurosurgical procedures. Neurosurgical procedures are associated fluctuations in ICP due to various reasons apart from patient surgical position. This together with the inherent CSF loss through dural incisions, use of external ventricular drains or external lumbar CSF drains can further alter CSF flow dynamics. These changes can also affect the CSF flow over the optic nerve sheath. This can be non-invasively measured by transbulbar sonography. Till date no published studies have analysed the effect of open neurosurgical procedures on CSF flow dynamics measured by ultrasonic optic nerve sheath assessment.

·         We aim to evaluate the Optic Nerve Sheath Diameter (ONSD) by ultrasonography in neurosurgical patients; undergoing craniotomy (elective and emergency) in varied surgical positions; preoperatively after induction of general anaesthesia and postoperatively before reversal of neuromuscular blokade.


 
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