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

Assessment of Increased Intracranial Pressure by Optic Nerve Sheath Diameter (ONSD), Eyeball Transverse Diameter (ETD) and ONSD/ETD Ratio Measurement From Ocular Ultrasound

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07784361
Acronym
ONSD ETD
Enrollment
68
Registered
2026-08-25
Start date
2026-08-30
Completion date
2026-10-30
Last updated
2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Pressure Increase, Laparoscopic Cholecystectomy Surgery, Optic Nerve Sheath Diameter Measurement

Keywords

ONSD, ETD, Laparoscopic Cholecystectomy, intracranial pressure increase

Brief summary

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.

Detailed description

Laparoscopic surgeries are now widely preferred in the treatment of gallbladder diseases. Carbon dioxide (CO₂) pneumoperitoneum created during laparoscopic surgery and the surgical positions applied can lead to temporary physiological changes in intracranial pressure (ICP). Increased intra-abdominal pressure can trigger an increase in ICP by reducing venous return, increasing intrathoracic pressure, and causing hypercapnia. Since direct measurement of increased intracranial pressure requires invasive methods, it is not applicable to every patient in clinical practice. Optic nerve sheath diameter (ONSD) measurement, performed with transorbital ultrasonography, is a non-invasive, bedside method that can indirectly reflect changes in ICP. Literature shows that an increase in ONSD correlates with increased ICP and can be a reliable monitoring method during laparoscopic surgeries. Furthermore, to reduce the impact of inter-individual ocular anatomical differences on measurement results, the ratio of optic nerve sheath diameter to eyeball transverse diameter (ONSD/ETD) will be calculated. The literature reports that the ONSD/ETD ratio exhibits lower variability compared to ONSD measurement alone and may be a more reliable parameter for reflecting intracranial pressure changes. However, studies comparing the effects of different gas insufflation pressures on ONSD/ETD in laparoscopic cholecystectomy surgeries are limited. Measurements of ONSD (On-Surgery Pressure) have shown that pneumoperitoneum created during these surgeries can increase intracranial pressure in both the early and late stages. Literature reports that ONSD values in the range of 5.0-5.9 mm may be associated with increased ICP. While current studies reveal the effects of pneumoperitoneum duration, surgical position, and hypercapnia on ICP, data on the comparative effects of different gas insufflation pressures are limited. Therefore, evaluating the effects of low and standard insufflation pressures on ONSD during laparoscopic cholecystectomy aims to fill this gap in the current literature. This study has the potential to contribute to determining safer pressure ranges in laparoscopic surgical procedures.

Interventions

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

PROCEDUREHigh Pressure Group

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

Sponsors

Gaziantep City Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients aged between 18 and 80 years. * Patients scheduled for laparoscopic cholecystectomy. * ASA (American Society of Anesthesiologists) physical status I or II.

Exclusion criteria

* History of intracranial space-occupying lesion or high intracranial pressure (ICP). * History of abdominal trauma. * History of orbital/ocular trauma.

Design outcomes

Primary

MeasureTime frameDescription
ONSD/ETDT1(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 ExsufflationOptic 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

Secondary

MeasureTime frameDescription
ONSDT1(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 ExsufflationOptic 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.
MAPT1(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 ExsufflationRecording Measurement of Mean Arterial Pressure (MAP) in mmHg during surgery

Contacts

CONTACTGamze Nur Teke, medical doctor
gamzenur.koca@gmail.com+905546694389

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026