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

StatusCompleted
PhasePhase 4
Started
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Record History

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  1. Minor Trial completed Show 5 more changesShow less
    • Primary completion date changed from estimate of Jul 10, 2026 to Sep 23, 2026
    • Interventions: Neostigmine + Atropine (Drug), Sugammadex 2 mg/kg (Drug) to Neostigmine + Atropine (Drug), Sugammadex 2 mg/kg (Drug)
    • Eligibility criteria expanded, about 11 words
    • Site details revised
    • Publications: details revised at 3 of 3 entries
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07666984
Lead Sponsor Cukurova University
Conditions
(from sponsor)
Neuromuscular Blockade Reversal Agent
Enrollment 86 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov