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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCukurova University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

With an ASA physical status of 1-2

Patients scheduled for elective surgery

Patients willing to participate in the study

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sugammadex 2 mg/kg

    Drug

    Intravenous bolus injection

  • Neostigmine + Atropine

    Drug

    Intravenous bolus injection

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: Group SActive comparator 1 intervention
Group B: Group NActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in average optic nerve sheath diameter from intubation to the 5th minute after extubation

Three measurements will be taken for each eye using ultrasound to determine the diameter of the optic nerve sheath at 5 minutes after endotracheal intubation, 5 minutes before extubation, and 5 minutes after extubation; the average values for each eye will be recorded. Subsequently, the averages of the measurements obtained for both eyes will be calculated. Changes in these averages over time will be compared between groups.

Time frame
From the time of endotracheal intubation until 5 minutes after extubation

Secondary outcomes

1

Blood Pressure

Blood pressure will be measured and recorded 5 minutes after endotracheal intubation, 5 minutes before extubation, and 5 minutes after extubation

Time frame
From the time of endotracheal intubation until 5 minutes after extubation
2

Postoperative nausea and vomiting

The number of patients who experienced nausea and vomiting upon waking from anesthesia and during their stay in the postoperative care unit.

Time frame
The one-hour period from endotracheal tube removal to patient discharge from the postoperative care unit.
3

Blood pressure

Noninvasive measurement of blood pressure

Time frame
The one-hour period from endotracheal tube removal to patient discharge from the postoperative care unit.

Other outcomes

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