Assessment of Optic Sheat Diameter (ONSD) and Eyeball Transverse Diameter (ETD) Ratio Measurement From Ocular Ultrasound

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorGaziantep City Hospital

About this trial

The aim of this study is to evaluate the effects of different carbon dioxide gas insufflation pressures on the ultrasound-guided optic nerve sheath diameter in patients undergoing laparoscopic cholecystectomy and to determine the possible relationship between these changes and intracranial pressure. The study aims to gain a better understanding of the neurophysiological effects of gas pressures used during laparoscopic surgery and to obtain scientific data aimed at improving patient safety.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged between 18 and 80 years.

Patients scheduled for laparoscopic cholecystectomy.

ASA (American Society of Anesthesiologists) physical status I or II.

Disqualifiers

History of intracranial space-occupying lesion or high intracranial pressure (ICP).

History of abdominal trauma.

History of orbital/ocular trauma.

Trial population

The study population consists of adult patients aged 18-80 years, classified as ASA I-II physical status, who are scheduled to undergo elective laparoscopic cholecystectomy in a tertiary care hospital setting. Patients are observed within the routine clinical workflow of the anesthesia and general surgery departments.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Low Pressure Group

    Procedure/Surgery

    Data will be collected on patients who underwent surgery within a pressure range of 10-14, depending on the surgeon's preference.

  • High Pressure Group

    Procedure/Surgery

    Data will be collected on patients who underwent surgery within a pressure range of 14-18, depending on the surgeon's preference.

Treatment groups

68 Participants
are divided into 1 treatment group
Group A: Laparoscopic Cholecystectomy2 interventions

Trial outcomes

Primary outcomes

1

ONSD/ETD

Optic nerve sheath diameter (ONSD) eyeball transverse diameter (ETD) ratio: The ONSD/ETD ratio will be calculated by dividing the mean ONSD value by the mean ETD value for each participant. This dimensionless ratio will be utilized as a standardized surrogate marker to evaluate changes in intracranial pressure (ICP), effectively minimizing confounding individual variations in eyeball size and ocular anatomy

Time frame
T1(Baseline):Before the induction of anesthesia T2(Post-Intubation):5 minutes after endotracheal intubation T3(Intra-Pneumoperitoneum):15 minutes after the establishment of pneumoperitoneum T4(Post-Exsufflation):10 minutes after complete Exsufflation

Secondary outcomes

1

ONSD

Optic Nerve Sheat Diameter during surgery: Optic nerve sheath diameter (ONSD) will be evaluated using high-resolution transbulbar ultrasonography to monitor real-time changes in intracranial pressure during the surgical procedure. A linear ultrasound probe will be placed gently over the closed eyelid using acoustic gel, ensuring minimal pressure on the globe.ONSD measurements will be performed bilaterally at a depth of 3 mm posterior to the retina, perpendicular to the optic nerve axis. The mean value of three consecutive measurements from each eye will be recorded for analysis.

Time frame
T1(Baseline):Before the induction of anesthesia T2(Post-Intubation):5 minutes after endotracheal intubation T3(Intra-Pneumoperitoneum):15 minutes after the establishment of pneumoperitoneum T4(Post-Exsufflation):10 minutes after complete Exsufflation
2

MAP

Recording Measurement of Mean Arterial Pressure (MAP) in mmHg during surgery

Time frame
T1(Baseline):Before the induction of anesthesia T2(Post-Intubation):5 minutes after endotracheal intubation T3(Intra-Pneumoperitoneum):15 minutes after the establishment of pneumoperitoneum T4(Post-Exsufflation):10 minutes after complete Exsufflation

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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