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

PHASE4CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

October 1, 2024

Primary Completion Date

January 17, 2025

Study Completion Date

January 20, 2025

Conditions
Sugammadex Reversal TimeMuscle Weakness
Interventions
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.

Trial Locations (1)

42050

Konya City Hospital, Konya

All Listed Sponsors
lead

Konya City Hospital

OTHER

NCT06623370 - The Effect of Methylprednisolone on the Reversal Time of Rocuronium by Sugammadex in the Pediatric Patient Group | Biotech Hunter | Biotech Hunter