CompletedNot Applicable

Optic Nerve Sheath Diameter Changes During Bariatric Surgery

Turkey (Türkiye)56 participantsStarted 2022-01-01

Plain-language summary

This prospective clinical study aimed to evaluate the effects of pneumoperitoneum and patient positioning on intracranial pressure in patients undergoing bariatric surgery. Intracranial pressure was assessed noninvasively using ultrasonographic optic nerve sheath diameter (ONSD) measurements. ONSD measurements were performed before anesthesia induction in the supine position (T0), 5 minutes after anesthesia induction (T1), 5 minutes after creation of pneumoperitoneum and placement in the reverse Trendelenburg position (T2), at the 20th minute of pneumoperitoneum (T3), and 5 minutes after termination of pneumoperitoneum and return to the supine position (T4). The study aimed to determine the effects of anesthesia, pneumoperitoneum, and surgical positioning on intracranial pressure during bariatric surgery

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: The study will include patients who have undergone bariatric surgery, are over 18 years of age, and belong to the ASA 1-ASA 3 risk group. Exclusion Criteria:Patients who do not wish to participate, those who have undergone cataract surgery, patients under 18 years of age, ASA 4 patients, patients with increased intracranial pressure, those with diseases that may cause increased intracranial pressure (hydrocephalus, stroke, brain tumor, etc.), those with eye pathology, and glaucoma patients will be excluded from the study. -

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Optic Nerve Sheath Diameter (ONSD)

Timeframe: Preoperative and perioperative period (T0, T1, T2, T3, and T4)

Trial details

NCT IDNCT07662538

SponsorFatih Sultan Mehmet Training and Research Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-01-30

View on ClinicalTrials.gov More Morbid Obesity trials