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

NCT06623370 | Completed Phase 4

• 1 other identifier: 34028104-799
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

sugammadex; methylprednisolone; reversal time; rocuronium; pediatric patients

Outcome Measures

Primary Outcomes (1)

• reversal time

  The time to reach a TOF ratio of 0.9 after sugammadex administration and the time until extubation will be recorded for all patients.

  The study will conclude after the patient has been postoperatively monitored for 2 hours in the recovery unit

Study Arms (2)

Group M

ACTIVE COMPARATOR

In addition to the routine anesthesia protocol, 1 mg/kg of methylprednisolone will be administered after induction.

Drug: methylprednisolone

Group C

PLACEBO COMPARATOR

Routine anesthesia will be administered.

Other: Saline (NaCl 0,9 %) (placebo)

Interventions

methylprednisolone DRUG

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.

Group M

Saline (NaCl 0,9 %) (placebo) OTHER

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.

Group C

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients who are able to provide informed consent and reliably report symptoms to the research team,
• Classified as Physical Status 1 and 2 according to the American Society of Anesthesiologists (ASA).

You may not qualify if:

• Patients for whom parental or personal consent could not be obtained
• ASA Physical Status 3 or higher
• Known history of allergic reactions to the drugs specified in the protocol
• Patients requiring emergency surgery
• Expected difficult airway
• Preoperative corticosteroid use
• Presence of respiratory system diseases
• Presence of neuromuscular diseases
• Presence of enzymatic or endocrine disorders
• Presence of liver or kidney failure
• Presence of cardiovascular diseases
• Patients with abnormal cognitive or physical development
• History of treatment with drugs that have a high potential for interaction with sugammadex (e.g., toremifene, flucloxacillin, fusidic acid).

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya City Hospital

Konya, Konya, 42050, Turkey (Türkiye)

Location

Related Publications (1)

• Buyukcavlak M, Tire Y, Mermer A, Yuce MS, Yildirim SN, Kozanhan B. The effect of methylprednisolone on the reversal time of rocuronium by sugammadex in the paediatric patient group: A randomised controlled trial. Eur J Anaesthesiol. 2025 Nov 1;42(11):1025-1033. doi: 10.1097/EJA.0000000000002241. Epub 2025 Jul 16.

  PMID: 40673736 DERIVED

MeSH Terms

Conditions

Muscle Weakness

Interventions

Methylprednisolone; Sodium Chloride

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: October 1, 2024
• Primary Completion: January 17, 2025
• Study Completion: January 20, 2025
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)