Neuromuscular Blockade Reversal Agent
Conditions
Keywords
Neuromuscular Blockade reversal agent, Optic nerve sheath diameter
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.
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.
Interventions
Intravenous bolus injection
Intravenous bolus injection
Sponsors
Study design
Eligibility
Inclusion criteria
* With an ASA physical status of 1-2 * Patients scheduled for elective surgery * Patients willing to participate in the study
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in average optic nerve sheath diameter from intubation to the 5th minute after extubation | From the time of endotracheal intubation until 5 minutes 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | From the time of endotracheal intubation until 5 minutes after extubation | Blood pressure will be measured and recorded 5 minutes after endotracheal intubation, 5 minutes before extubation, and 5 minutes after extubation |
| Postoperative nausea and vomiting | The one-hour period from endotracheal tube removal to patient discharge from the postoperative care unit. | The number of patients who experienced nausea and vomiting upon waking from anesthesia and during their stay in the postoperative care unit. |
| Blood pressure | The one-hour period from endotracheal tube removal to patient discharge from the postoperative care unit. | Noninvasive measurement of blood pressure |
Countries
Turkey (Türkiye)
Contacts
Cukurova University