NCT06623370

The Effect of Methylprednisolone on the Reversal Time of Rocuronium by Sugammadex in the Pediatric Patient Group

The Effect of Methylprednisolone Administration on the Reversal Time of Rocuronium by Sugammadex in the Pediatric Patient Group

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Konya City Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to thoroughly investigate the interaction between methylprednisolone and sugammadex in the pediatric patient population. Our hypothesis is that methylprednisolone will interact with sugammadex, leading to a prolonged reversal time of rocuronium by sugammadex and, at the same time, a reduction in the effect profile of methylprednisolone. Approximately 80 volunteers will be included in the study. Patients will not have any additional responsibilities related to this study. There are no risks or benefits to patients associated with this research. The study will begin immediately before the patient's surgery and will end two hours after the operation. Volunteers participating in the study will be randomly assigned to one of two groups: one group will receive methylprednisolone during surgery, and the other group will not. Methylprednisolone is a medication used to prevent postoperative pain, swelling, nausea, and vomiting. If these complaints are detected in patients from either group after surgery, appropriate treatments will be administered to alleviate them.

Conditions

• Sugammadex Reversal Time
• Muscle Weakness

Interventions

Type	Name	Description
DRUG	methylprednisolone	Patients will undergo standard noninvasive blood pressure monitoring, electrocardiogram, peripheral oxygen saturation (SpO2), and capnography. After anesthesia induction, neuromuscular monitoring will also be applied. Anesthesia induction will be performed with 2-4 mg/kg propofol and 1 mcg/kg fentanyl. First group (Group M), patients will receive 1 mg/kg methylprednisolone , while in the second group (Group C), patients will receive 5 ml of normal saline. Immediately afterward, the neuromuscular monitor will be set to measure the Train of Four (TOF). Following this, 0.6-1.2 mg/kg of rocuronium will be administered intravenously. If necessary, additional doses of 0.15 mg/kg rocuronium will be given during the operation when TOF count reaches T2. For postoperative analgesia, 15 mg/kg of i.v. paracetamol will be administered. At the end of the surgery, when anesthesia is terminated and T2 reappears in TOF count, all patients will receive a single bolus injection of sugammadex.
OTHER	Saline (NaCl 0,9 %) (placebo)	Patients will undergo standard noninvasive blood pressure monitoring, electrocardiogram, peripheral oxygen saturation (SpO2), and capnography. After anesthesia induction, neuromuscular monitoring will also be applied. Anesthesia induction will be performed with 2-4 mg/kg propofol and 1 mcg/kg fentanyl. First group (Group M), patients will receive 1 mg/kg methylprednisolone , while in the second group (Group C), patients will receive 5 ml of normal saline. Immediately afterward, the neuromuscular monitor will be set to measure the Train of Four (TOF). Following this, 0.6-1.2 mg/kg of rocuronium will be administered intravenously. If necessary, additional doses of 0.15 mg/kg rocuronium will be given during the operation when TOF count reaches T2. For postoperative analgesia, 15 mg/kg of i.v. paracetamol will be administered. At the end of the surgery, when anesthesia is terminated and T2 reappears in TOF count, all patients will receive a single bolus injection of sugammadex.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-01-17
• Completion: 2025-01-20
• First posted: 2024-10-02
• Last updated: 2025-01-30

Locations

1 site across 1 country: Turkey (Türkiye)