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).
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.
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.
- Conditions
- Neuromuscular Blockade Reversal Agent
- 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 group | Role | What they receive |
|---|---|---|
| Group S | Active comparator | Sugammadex, intravenous, 2 mg/kg, single bolus dose. Receives: Drug: Sugammadex 2 mg/kg |
| Group N | Active comparator | Neostigmine, 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.
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)
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
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.
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.
- First posted24 Jun 2026
- Study start25 Jun 2026
- Primary completion23 Sep 2026
- Study completion23 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular Blockade Reversal AgentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ersel GULEC, Cukurova University
- Investigators
- Ersel Gulec, MD, Principal investigator, Cukurova University
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 21769456Maissan 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 25955869P 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