[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653247":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":24,"studyPopulation":25,"armGroups":26,"interventions":33,"overallOfficials":20,"centralContacts":43,"locations":20,"responsibleParty":49,"collaborators":20,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":20,"briefSummary":68,"conditions":69,"keywords":73,"overallStatus":76,"whyStopped":20,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":20},{"fullName":5,"class":6},"Gaziantep City Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"ONSD\u002FETD","Optic nerve sheath diameter (ONSD) eyeball transverse diameter (ETD) ratio: The ONSD\u002FETD 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","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",[14,17],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":12},"MAP","Recording Measurement of Mean Arterial Pressure (MAP) in mmHg during surgery",null,{"allocation":20,"interventionModel":20,"interventionModelDescription":20,"primaryPurpose":20,"observationalModel":22,"timePerspective":23,"maskingInfo":20},"COHORT","PROSPECTIVE","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\u002FETD) will be calculated. The literature reports that the ONSD\u002FETD 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\u002FETD in laparoscopic cholecystectomy surgeries are limited.\n\nMeasurements 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.","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.",[27],{"label":28,"type":20,"description":29,"interventionNames":30},"Laparoscopic Cholecystectomy","Observation of patients undergoing laparoscopic cholecystectomy under either low or high gas insufflation pressure determined by the clinical routine. Optic nerve sheath diameter (ONSD) and eyeball transverse diameter (ETD) will be measured via non-invasive transorbital ultrasonography.",[31,32],"Procedure: Low Pressure Group","Procedure: High Pressure Group",[34,39],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":20},"PROCEDURE","Low Pressure Group","Data will be collected on patients who underwent surgery within a pressure range of 10-14, depending on the surgeon's preference.",[28],{"type":35,"name":40,"description":41,"armGroupLabels":42,"otherNames":20},"High Pressure Group","Data will be collected on patients who underwent surgery within a pressure range of 14-18, depending on the surgeon's preference.",[28],[44],{"name":45,"role":46,"phone":47,"phoneExt":20,"email":48},"Gamze Nur Teke, medical doctor","CONTACT","+905546694389","gamzenur.koca@gmail.com",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Gamze Nur Teke","medical doctor","100653247","assessment-of-optic-sheat-diameter-onsd-and-eyeball-transverse-diameter-etd-ratio-measurement-from-ocular-ultrasound-100653247",false,"NCT07784361","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\u002FETD Ratio Measurement From Ocular Ultrasound","ONSD ETD","Inclusion Criteria:\n\n* Patients aged between 18 and 80 years.\n* Patients scheduled for laparoscopic cholecystectomy.\n* ASA (American Society of Anesthesiologists) physical status I or II.\n\nExclusion Criteria:\n\n* History of intracranial space-occupying lesion or high intracranial pressure (ICP).\n* History of abdominal trauma.\n* History of orbital\u002Focular trauma.","ALL","18 Years","80 Years",{"count":65,"type":66},68,"ESTIMATED","OBSERVATIONAL","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.",[70,71,72],"Optic Nerve Sheath Diameter Measurement","Intracranial Pressure Increase","Laparoscopic Cholecystectomy Surgery",[15,74,28,75],"ETD","intracranial pressure increase","NOT_YET_RECRUITING","2026-08-20",{"date":79,"type":80},"2026-08-25","ACTUAL",{"date":82,"type":66},"2026-08-30",{"date":84,"type":66},"2026-10-30",{"name":5,"class":6}]