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Neuromuscular Blockade Reversal AgentPhase 4NCT07666984

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

A Phase 4 study testing Sugammadex 2 mg/kg and Neostigmine + Atropine in people with Neuromuscular Blockade Reversal Agent, run by Cukurova University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Neuromuscular Blockade Reversal Agent
What is being tested?
Sugammadex 2 mg/kg and Neostigmine + Atropine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Jun 2026to 23 Sep 2026
Phase
Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • With an ASA physical status of 1-2
  • Patients scheduled for elective surgery
  • Patients willing to participate in the study

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Cukurova University Faculty of Medicine

    Adana

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Effects of Neostigmine and Sugammadex on the Optic Nerve Sheath Diameter During the Postoperative Extubation Period

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.

Read the detailed description

The study will be conducted prospectively, randomly, and double-blind on a total of 86 patients aged 18-65 years, classified as ASA 1-2, undergoing elective surgery at the Department of Anesthesiology and Reanimation, Faculty of Medicine, Çukurova University. Written and verbal informed consent will be obtained from all participants prior to the study.

The demographic data, such as age, gender, body weight, and height, as well as ASA score and information on comorbidities, will be recorded for the patients included in the study in the preoperative anesthesia care unit. All patients who will be taken to the operating room without premedication will undergo routine monitoring, including electrocardiography, noninvasive blood pressure monitoring, and peripheral oxygen saturation. During induction of anesthesia, propofol IV 2 mg/kg, rocuronium IV 0.6 mg/kg, and fentanyl IV 1 mcg/kg will be used. After observing adequate muscle relaxation with a TOF (Train-of-Four) monitor, tracheal intubation will be performed. All patients will receive mechanical ventilation after intubation. During anesthesia, a gas mixture of 2% sevoflurane, 60% nitrous oxide, and 40% oxygen will be administered at a flow rate of 2 L/min. To maintain muscle relaxation throughout the surgery, when a TOF of 2 is observed, 0.2 mg/kg of rocuronium IV will be administered. Tramadol 2 mg/kg IV will be given 45 minutes before the end of surgery for postoperative pain management. Ondansetron 8 mg IV will be planned as antiemetic treatment. At the end of the surgery, the maintenance gases will be discontinued, and according to the randomization, the anesthesiologist responsible for anesthesia administration will either administer 2 mg/kg Sugammadex IV or 0.05 mg/kg Neostigmine IV plus 0.02 mg/kg atropine sulfate IV. Patients who show a TOF value of 90% and clinically adequate respiration will be extubated.

In addition to the anesthesiologist responsible for administering anesthesia, one blinded evaluator for each group will perform three ultrasound measurements on both eyes to determine the Optic nerve sheath diameter at 5 minutes after endotracheal intubation, 5 minutes before extubation, and 5 minutes after extubation. The measurements will be recorded while the patient is in a supine position, with ultrasound gel applied to the eyelid, using a linear probe without applying pressure to the eyeball.

The diameter of the optic nerve sheath will be systematically measured at a point 3.0 mm posterior to the optic disc to ensure consistent anatomical evaluation.

Being tested
Sugammadex 2 mg/kg, Neostigmine + Atropine
Keywords
Neuromuscular Blockade reversal agent, Optic nerve sheath diameter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sugammadex 2 mg/kgDrug

    Intravenous bolus injection

  • Neostigmine + AtropineDrug

    Intravenous bolus injection

Study groups in NCT07666984
Study groupRoleWhat they receive
Group SActive comparatorSugammadex, intravenous, 2 mg/kg, single bolus dose.
Receives: Drug: Sugammadex 2 mg/kg
Group NActive comparatorNeostigmine, intravenous, 0.05 mg/kg, single bolus dose. Atropine sulfate, intravenous, 0.02 mg/kg, single bolus dose.
Receives: Drug: Neostigmine + Atropine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)
  1. Blood Pressure

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

    Measured: 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.

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

  3. Blood pressure

    Noninvasive measurement of blood pressure

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2026
  2. Study start25 Jun 2026
  3. Primary completion23 Sep 2026
  4. Study completion23 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07666984
Sponsor's protocol ID
25-AKD-309
Status last verified
Oct 2026
First submitted
8 Jun 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected IPD may be shared with relevant parties upon request, with the principal investigator's approval, provided that no personally identifiable information or hospital records are disclosed.

Publications

  • Rajajee V, Vanaman M, Fletcher JJ, Jacobs TL. Optic nerve ultrasound for the detection of raised intracranial pressure. Neurocrit Care. 2011 Dec;15(3):506-15. doi: 10.1007/s12028-011-9606-8.

    PubMed 21769456
  • Maissan IM, Dirven PJ, Haitsma IK, Hoeks SE, Gommers D, Stolker RJ. Ultrasonographic measured optic nerve sheath diameter as an accurate and quick monitor for changes in intracranial pressure. J Neurosurg. 2015 Sep;123(3):743-7. doi: 10.3171/2014.10.JNS141197. Epub 2015 May 8.

    PubMed 25955869
  • P S L, Miskan MM, Y Z C, Zaki RA. Staggering the dose of sugammadex lowers risks for severe emergence cough: a randomized control trial. BMC Anesthesiol. 2017 Oct 11;17(1):137. doi: 10.1186/s12871-017-0430-3.

    PubMed 29020936

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