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CTRI Number  CTRI/2025/09/094599 [Registered on: 11/09/2025] Trial Registered Prospectively
Last Modified On: 10/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Observational physiological measurement study 
Study Design  Other 
Public Title of Study   Study on patients undergoing laparoscopic surgery to see how body position and gas inflation affect brain pressure using eye ultrasound 
Scientific Title of Study   Effect of pneumoperitoneum and Trendelenburg position on intracranial pressure assessed using transorbital ultrasonographic measurement of optic nerve sheath diameter in patients undergoing laparoscopic surgery An observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jinan R S 
Designation  Junior Resident, Department of Anaesthesiology, Government Medical College, Kozhikode 
Affiliation  Government Medical College, Kozhikode 
Address  Government Medical College, Kozhikode
Department of Anaesthesiology, Government Medical College, Kozhikode, Kerala, India, 673008
Kozhikode
KERALA
673008
India 
Phone  7558859110  
Fax    
Email  jinanrs107101@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Binu Sajid 
Designation  Professor, Department of Anaesthesiology, Government Medical College, Kozhikode 
Affiliation  Government Medical College, Kozhikode 
Address  Government Medical College, Kozhikode
Department of Anaesthesiology, Government Medical College, Kozhikode, Kerala, India, 673008
Kozhikode
KERALA
673008
India 
Phone  9447324632  
Fax    
Email  binusajid@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Jinan R S 
Designation  Junior Resident, Department of Anaesthesiology, Government Medical College, Kozhikode 
Affiliation  Government Medical College, Kozhikode 
Address  Government Medical College, Kozhikode
Department of Anaesthesiology, Government Medical College, Kozhikode, Kerala, India, 673008
Kozhikode
KERALA
673008
India 
Phone  7558859110  
Fax    
Email  jinanrs107101@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College, Kozhikode Medical College P O, Kozhikode, Kerala, India – 673008 
 
Primary Sponsor  
Name  Department of anaesthesiology 
Address  Department of anaesthesiology , Government medical college Kozhikode, 673008 
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 Jinan R S  Government Medical College, Kozhikode  Department of Anaesthesiology, Government Medical College, Medical College P.O., Kozhikode – 673008, Kerala, India
Kozhikode
KERALA 		 7558859110

jinanrs107101@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Government medical college Kozhikode  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G938||Other specified disorders of brain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age between twenty one and sixty years
Both male and female patients
American Society of Anesthesiologists (ASA) physical status one to three
Body mass index less than thirty kilograms per square metre
Scheduled for elective laparoscopic surgery with pneumoperitoneum and Trendelenburg position under general anaesthesia
Glasgow coma score of fifteen 
 
ExclusionCriteria 
Details  History of ophthalmic problems that prevent proper use of ultrasound probe
Presence of optic nerve disorders such as optic neuritis or optic nerve neoplasm
Previous ocular surgery
Hyperthyroidism 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the change in intracranial pressure in patients undergoing laparoscopic surgery with combined pneumoperitoneum and Trendelenburg position under general anaesthesia, measured by transorbital ultrasonographic optic nerve sheath diameter (ONSD).  Baseline (before pneumoperitoneum), after creation of pneumoperitoneum in Trendelenburg position, and after desufflation before extubation. 
 
Secondary Outcome  
Outcome  TimePoints 
Change in mean arterial pressure (MAP) and heart rate in relation to ONSD changes.  Baseline (before pneumoperitoneum), after creation of pneumoperitoneum in Trendelenburg position, and after desufflation before extubation. 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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)   21/09/2025 
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)   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 - NO
Brief Summary  

This observational study aims to assess the effect of pneumoperitoneum and Trendelenburg position on intracranial pressure in patients undergoing laparoscopic surgery under general anaesthesia. Intracranial pressure will be estimated using transorbital ultrasonographic measurement of optic nerve sheath diameter (ONSD) at predefined time points. The hypothesis is that combined pneumoperitoneum and Trendelenburg position increases ONSD, reflecting a rise in intracranial pressure. Secondary objectives include evaluating the correlation of ONSD with end-tidal carbon dioxide and haemodynamic parameters.

 
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