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Clinical Trials/CTRI/2025/09/094599
CTRI/2025/09/094599
Not yet recruiting
Not Applicable

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

Department of anaesthesiology1 site in 1 country38 target enrollmentStarted: September 21, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Department of anaesthesiology
Enrollment
38
Locations
1
Primary Endpoint
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).

Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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).

Time Frame: Baseline (before pneumoperitoneum), after creation of pneumoperitoneum in Trendelenburg position, and after desufflation before extubation.

Secondary Outcomes

  • 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.)

Investigators

Sponsor
Department of anaesthesiology
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Jinan R S

Government Medical College, Kozhikode

Study Sites (1)

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