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

NCT07666984 | Recruiting Phase 4

• 1 other identifier: 25-AKD-309
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuromuscular Blockade Reversal Agent

Keywords

Neuromuscular Blockade reversal agent; Optic nerve sheath diameter

Outcome Measures

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.

  From the time of endotracheal intubation until 5 minutes after extubation

Secondary Outcomes (3)

• Blood Pressure

  From the time of endotracheal intubation until 5 minutes after extubation

• Postoperative nausea and vomiting

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

• Blood pressure

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

Study Arms (2)

Group S

ACTIVE COMPARATOR

Sugammadex, intravenous, 2 mg/kg, single bolus dose.

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.

Drug: Neostigmine + Atropine

Interventions

Sugammadex 2 mg/kg DRUG

Intravenous bolus injection

Group S

Neostigmine + Atropine DRUG

Intravenous bolus injection

Group N

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University Faculty of Medicine

Adana, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 21769456 BACKGROUND

• 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.

  PMID: 25955869 BACKGROUND

• 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.

  PMID: 29020936 BACKGROUND

MeSH Terms

Interventions

Sugammadex; Neostigmine; Atropine

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Ersel Gulec, MD

  Cukurova University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ersel Gulec, MD

CONTACT

+903223386060; gulecersel@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 24, 2026
• Study Start: June 4, 2026
• Primary Completion: July 10, 2026
• Study Completion: July 10, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)