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

Phase 4

Completed

• Conditions: Sugammadex Reversal Time; Muscle Weakness
• Interventions: Other: Saline (NaCl 0,9 %) (placebo); Drug: methylprednisolone

• Registration Number: NCT06623370
• Lead Sponsor: Konya City Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-30
• Study First Submitted QC: 2024-09-30
• Study Start: 2024-10-01
• Study First Posted: 2024-10-02
• Status Verified: 2025-01
• Primary Completion: 2025-01-17
• Study Completion: 2025-01-20
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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).

Exclusion Criteria

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Saline (NaCl 0,9 %) (placebo)	Routine anesthesia will be administered.
Group M	methylprednisolone	In addition to the routine anesthesia protocol, 1 mg/kg of methylprednisolone will be administered after induction.

Primary Outcome Measures

Name	Time	Method
reversal time	The study will conclude after the patient has been postoperatively monitored for 2 hours in the recovery unit	The time to reach a TOF ratio of 0.9 after sugammadex administration and the time until extubation will be recorded for all patients.

Trial Locations

Locations (1)

Konya City Hospital; 🇹🇷 Konya, Turkey