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Clinical Trials/CTRI/2025/09/095279
CTRI/2025/09/095279RecruitingNot Applicable

Effect of Ventilation mode on Optic Nerve Sheath Diameter in patients undergoing laparoscopic surgery: A randomised study

University College of Medical Sciences1 site in 1 country56 target enrollmentStarted: October 10, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
56
Locations
1
Primary Endpoint
ONSD

Study Overview

Brief Summary

Participants will be randomly allocated to either group V or group P. Monitors will be attached and general anaesthesia will be induced. Mode of ventilation will be kept as per the group allocated. Ventilation will be adjusted to maintain ETCO2 within 35-40 mmHg. ONSD, respiratory parameters, hemodynamics and blood gas parameters will be assessed before induction, 1 and 5 min after intubation, 10, 30 and 60 min after pneumoperitoneum, just before deflation and 5 min after extubation.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

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

Inclusion Criteria

  • ASA I and II BMI less than 30 kg per metre square.

Exclusion Criteria

  • history of eye surgery or known case of eye disease like cataract, glaucoma, uncontrolled cardiovascular, respiratory, renal, liver disease brain tumors, epilepsy or other causes which raise ICP, history of head injury or brain surgery.

Outcomes

Primary Outcomes

ONSD

Time Frame: Before Induction | 1 min after intubation | 5 min after intubation | 10 min after pneumoperitoneum | 30 min after pneumoperitoneum | 60 min after pneumoperitoneum | Just before deflation | 5 min after extubation

Secondary Outcomes

  • Respiratory parameters: Tidal volume, respiratory rate, minute ventilation (MV), EtCO2, Peak pressure (Ppeak), mean airway pressure (Pmean), SpO2(3. Blood gas parameters: PaO2, PaCO2, pH, PaO2/FiO2 ratio)

Investigators

Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Poonam

University College of Medical Sciences and Guru Teg Bahadur Hospital Delhi

Study Sites (1)

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