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CTRI Number  CTRI/2025/07/091095 [Registered on: 17/07/2025] Trial Registered Prospectively
Last Modified On: 15/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Measuring the thickness of optic nerve and eye ball size using USG AND CT scan using their correlation with pressure in the brain for predicting the neurological outcome  
Scientific Title of Study   Evaluation of optic nerve sheath diameter to transverse diameter ratio for predicting the neurological outcome in patients undergoing supratentorial craniotomy: Comparison of USG AND CT Measurements  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ARUN UNNITHAN 
Designation  Junior Resident  
Affiliation  King Georges Medical University, Lucknow 
Address  Junior Resident, Department of Anaesthesiology, King Georges Medical University, Shah Mina Road, Chowk, Lucknow 226003 Uttar Pradesh.

Lucknow
UTTAR PRADESH
226003
India 
Phone  9400440544  
Fax    
Email  arunmvjgd@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR HEMLATA  
Designation  Additional Professor  
Affiliation  King Georges Medical University, Lucknow  
Address  Additional Professor, Department of Anaesthesiology, King Georges Medical University, Shah Mina Road, Chowk, Lucknow 226003 Uttar Pradesh.

Lucknow
UTTAR PRADESH
226003
India 
Phone  9415410236  
Fax    
Email  hema2211@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  DR HEMLATA  
Designation  Additional Professor  
Affiliation  King Georges Medical University, Lucknow  
Address  Additional Professor, Department of Anaesthesiology, King Georges Medical University, Shah Mina Road, Chowk, Lucknow 226003 Uttar Pradesh.

Lucknow
UTTAR PRADESH
226003
India 
Phone  9415410236  
Fax    
Email  hema2211@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, King Georges Medical University, Shah Mina Road, Chowk, Lucknow 226003 Uttar Pradesh.  
 
Primary Sponsor  
Name  KING GEORGE MEDICAL UNIVERSITY  
Address  Department of Anaesthesiology, King Georges Medical University, Shah Mina Road, Chowk, Lucknow 226003 Uttar Pradesh.  
Type of Sponsor  Government medical college 
 
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 ARUN UNNITHAN  Neurosurgery department OT KING GEORGE,S MEDICAL UNIVERSITY  KING GEORGE,S MEDICAL UNIVERSITY ,SHAH MINA ROAD CHOWK, LUCKNOW
Lucknow
UTTAR PRADESH 		 9400440544

arunmvjgd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D330||Benign neoplasm of brain, supratentorial,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  USG AND CT guided measurement of optic nerve sheath diameter and eyeball transverse diameter and measuring intracranial pressure.  Optic nerve sheath diameter and eyeball transverse diameter will be measured by computed tomography and with the help of ultrasound machine we will also measure the optic nerve diameter and eye ball transverse diameter the neurosurgeon will insert then the intracranial pressure catheter through the burr hole made on the contralateral side of craniotomy and the catheter will be inserted into the subdural space for measurement of intracranial pressure and will be connected to the monitor The opening pressure will be recorded.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with large supratentorial tumor of size more than 4cm in diameter on CT scan posted for craniotomy and excision.
ASA grade 1-3
 
 
ExclusionCriteria 
Details  Ocular problems that could influence the ONSD or ETD,
Optic nerve injury,
Previous intracranial lesions/Craniotomy.
Lumbar puncture performed within 2 weeks before study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To measure ONSD/ETD ratio using both the techniques and find their correlation with ICP value measured invasively.  pre operative period and before induction ,intra operatively. 
 
Secondary Outcome  
Outcome  TimePoints 
-To find the correlation between ONSD/ETD ratio and neurological outcomes at 3 months (using Extended Glasgow Outcome Score (GOS-E))
-To compare the two techniques for their ability to predict the neurological outcomes at 3 months.
- To monitor hemodynamic parameters (HR & MAP) in perioperative period
- Brain Relaxation Score
-Time to extubation
-Length of hospital stay
-Neurological status at the time of extubation & discharge.
-Neurological outcome at the end of 3 months using Extended Glasgow Outcome Score (GOS-E).
-Complications if any during perioperative period
 		 pre operative period , intra and post operative period .and at time of discharge and after 3 months 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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)   26/07/2025 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  


METHODOLGY

After Institutional Ethics Committee approval & Written Informed Consent, patients undergoing elective supratentorial craniotomy and tumour excision and fulfilling inclusion criteria will be included in the study.

During the preoperative period, optic nerve sheath diameter and eyeball transverse diameter will be measured by computed tomography.

CT GUIDED TECHNIQUE

The CT scans will be performed on a spiral scanner (64 row with a tube voltage of 120 kV, tube current of 200–300 mA, slice thickness of 2 mm, slice interval of 3 mm, and pitch of 1.

The ONSD and ETD will be measured at a fixed mediastinal window (width, 300; level, 35) for the same contrast and brightness. The direction of the optic nerve is identified by three-dimensional reconstruction of brain CT data, and the ONSD will be measured 3 mm behind the eyeball. ETD will be measured from one side of the retina behind the lens to the other for the maximum diameter. All of the measurements of ONSD and ETD will be performed bilaterally, and the mean value will be considered to calculate the ONSD/ETD ratio.

 



 

As per institutional protocol, all patients will be examined on the night before surgery, and instruction regarding NPO, premedication will be given and all patients will be explained about USG-guided ONSD and ETD measurement for ICP assessment.

After taking the patient into the operation theatre, all standard monitors will be attached and IV-line will be secured. After making the patient comfortable and relaxed, we will measure the optic nerve diameter and eye ball transverse diameter with the help of USG machine before induction of anaesthesia

A linear 6-13 MHz probe of portable Sonosite Turbo-M ultrasonography (Fujifilm Sonosite, Bothell, USA) machine will be placed carefully on the gel over the closed (adhesive tape) upper eyelid without exerting pressure on the eye. In the two- dimensional mode, ONSD will be measured 3 mm below the junction site between the eyeball and optic nerve on a transverse line bilaterally, the values will be recorded for both the eyes. Average of three recordings for each eye will be taken separately for that par ticular point of time.


 

 

 

 

      The eyeball transverse diameter ETD (retina to retina) is defined as the maximal               

      transverse diameter of the eyeball obtained by scanning from the superior to the     

      inferior side. Average of three recordings for each eye will be taken separately for that   

        particular point of time.

Anaesthesia induction will be achieved with intravenous (IV) fentanyl 2µg/kg and propofol 2mg/kg. Patient will be intubated after adequate muscle relaxation with vecuronium 0.1mg/kg with appropriate size cuffed endotracheal tube. Maintenance of anaesthesia will be done with 60% air and 40% oxygen,1.5-2.0% sevoflurane with desired MAC up to 0.8-1.0 along with continuous infusion of vecuronium @0.03mg/kg/hr intravenously, supplemented with intravenous fentanyl 1.0 mcg/kg/hr. Patient will be ventilated with volume- controlled mode and end tidal carbon dioxide (ETCO2) will be maintained between 30-35mm Hg. Arterial catheter and central venous catheter (CVC) will be placed under USG guidance

The neurosurgeon will insert the intracranial pressure (ICP) catheter (subdural bolt) through the burr hole made on the contralateral side of craniotomy.

The catheter will be inserted into the subdural space for measurement of intracranial pressure and will be connected to the ICP monitor. The opening ICP will be recorded.

Cerebral perfusion pressure (CPP) will be measured as per below formulae:

 

Formula: CPP = MAP – ICP

 

Where,

MAP = Mean arterial pressure.

 ICP = Intra Cranial pressure.

 

Brain relaxation score will be assessed by the operating surgeon immediately on opening the duramater on a four-point scale (1=adequately relaxed, 2=satisfactorily relaxed, 3=firm brain, 4=bulging brain). Heart rate (HR), MAP, EtCo2, CVP, will be monitored continuously and recorded at 30 minutes interval till end of surgery. Fluid intake, urine output and blood loss will be recorded at the interval of 1 hour till the end of surgery. ABG, serum electrolytes and osmolarity will be first recorded at the start of surgery and will be taken as base line value, thereafter it will be analyzed at the interval of 1 hour till the end of surgery.

During intraoperative period, patient will be looked for any complications like Hypotension, Hyponatremia, Hypernatremia, Hypokalemia, Hyperkalemia and will be treated accordingly.

At the end of surgery further course will be decided by the discretion of anesthesiologist (extubation/postoperative ventilation). Patients not fulfilling the criteria for extubation will be shifted to Intensive Care Unit (ICU) for ventilation and delayed extubation, whereas others will be extubated after reversal of neuromuscular blockade with injection neostigmine (0.05 mg/kg) and glycopyrrolate (0.01 mg/kg)

The time to extubation will be recorded. Neurological status of patients at the time of extubation and at the time of discharge will be recorded.

The patient will be followed till the discharge from the hospital and neurological outcome with

 Extended Glasgow Outcome Scale (GOS- E) will be recorded over telephone at the end of 3

 months


 
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