drugset / Trial / NCT07175623
Methylprednisolone vs Dexamethasone Interaction With Sugammadex in Pediatric Patients
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This randomized controlled trial aims to compare the interaction of methylprednisolone and dexamethasone with sugammadex in pediatric patients undergoing adenoidectomy and/or tonsillectomy. The primary objective is to evaluate the effect of these corticosteroids on the reversal time of rocuronium-induced neuromuscular block by sugammadex. Secondary outcomes include postoperative pain, nausea and vomiting, extubation time, and adverse events. Eligible participants are children aged 5 to 12 years, ASA I-II, scheduled for elective surgery under general anesthesia. The study is designed as a triple-blind, parallel-group trial with three arms: methylprednisolone, dexamethasone, and placebo.
Timeline
- Start
- 2025-09-16
- Primary completion
- 2025-12-20
- Completion
- 2025-12-20
Publications
- Background Gulec E, Biricik E, Turktan M, Hatipoglu Z, Unlugenc H. The Effect of Intravenous Dexamethasone on Sugammadex Reversal Time in Children Undergoing Adenotonsillectomy. Anesth Analg. 2016 Apr;122(4):1147-52. doi: 10.1213/ANE.0000000000001142.
- Background Buonanno P, Laiola A, Palumbo C, Spinelli G, Servillo G, Di Minno RM, Cafiero T, Di Iorio C. Dexamethasone Does Not Inhibit Sugammadex Reversal After Rocuronium-Induced Neuromuscular Block. Anesth Analg. 2016 Jun;122(6):1826-30. doi: 10.1213/ANE.0000000000001294.
- Background Murphy GS, Sherwani SS, Szokol JW, Avram MJ, Greenberg SB, Patel KM, Wade LD, Vaughn J, Gray J. Small-dose dexamethasone improves quality of recovery scores after elective cardiac surgery: a randomized, double-blind, placebo-controlled study. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):950-60. doi: 10.1053/j.jvca.2011.03.002. Epub 2011 May 11.
- Background . Gold SJA, Harper NJN. The place of sugammadex in anaesthesia practice. Trends Anaesth Crit Care 2012; 2: 4-9.
- Background Graham LA, Illarmo S, Wren SM, Mudumbai SC, Odden MC. Optimal multimodal analgesia combinations to reduce pain and opioid use following non-cardiac surgery: an instrumental variable analysis. Reg Anesth Pain Med. 2025 Jul 17:rapm-2025-106720. doi: 10.1136/rapm-2025-106720. Online ahead of print.
- Background Aouad MT, Nasr VG, Yazbeck-Karam VG, Bitar MA, Bou Khalil M, Beyrouthy O, Harfouche D, Terrin N, Siddik-Sayyid S. A comparison between dexamethasone and methylprednisolone for vomiting prophylaxis after tonsillectomy in inpatient children: a randomized trial. Anesth Analg. 2012 Oct;115(4):913-20. doi: 10.1213/ANE.0b013e3182652a6a. Epub 2012 Jul 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 0.2 mg/kg | Intravenous |
| Subject | Methylprednisolone | Other / unclassified | 1 mg/kg | Intravenous |