RecruitingPhase 4

The Effect of Neostigmine and Sugammadex on the Optic Nerve Sheath Diameter

Turkey (Türkiye)86 participantsStarted 2026-06-04

Plain-language summary

This study will compare how two drugs, sugammadex and neostigmine-used to reverse muscle relaxation after surgery-affect the size of the optic nerve sheath (the nerve behind the eye) as patients wake up and have their breathing tubes removed. It will also examine the relationship between changes in blood pressure and heart rate during this time and these measurements. This study will be conducted on 86 healthy patients aged 18-65 who will undergo planned surgery at the Çukurova University Faculty of Medicine, Department of Anesthesiology and Reanimation. Patients will be randomly divided into two groups: the sugammadex group and the neostigmine group. All patients will receive standard general anesthesia and rocuronium to relax their muscles. At the end of the surgery, to reverse this effect, patients will be given either sugammadex or a mix of neostigmine and atropine. Group S will receive 2 mg sugammadex per kg, while Group N will receive 0.05 mg neostigmine and 0.02 mg atropine per kg. The width of the optic nerve sheath will be measured by ultrasound 5 minutes after the breathing tube is inserted, 5 minutes before the tube is removed, and 5 minutes after it is removed. Additionally, blood pressure, heart rate, and any complications during the surgery will be tracked and compared between the groups.

Who can participate

Age range

18 Years – 65 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: * With an ASA physical status of 1-2 * Patients scheduled for elective surgery * Patients willing to participate in the study Exclusion Criteria: * Patients with heart, liver, kidney, or respiratory failure * Brain tumors, hemorrhages, or aneurysms * Patients who have undergone eye, cardiovascular, or neurosurgery * Eye or neurological diseases or increased intracranial pressure * Laparoscopic surgeries * Cases not in the supine position * Allergy to the medications used * Patients who did not provide informed consent to participate in 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 average optic nerve sheath diameter from intubation to the 5th minute after extubation

Timeframe: From the time of endotracheal intubation until 5 minutes after extubation

Trial details

NCT IDNCT07666984

SponsorCukurova University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-10

Contact for this trial

Ersel Gulec, MD

+903223386060 gulecersel@yahoo.com

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