Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Neuromuscular blocking agents (NMBAs) are widely used in pediatric anesthesia to facilitate tracheal intubation and optimize surgical conditions. However, residual neuromuscular block may increase the risk of postoperative respiratory complications, especially in children who have shorter safe apnea times due to their unique anatomical and physiological characteristics. Sugammadex, a modified γ-cyclodextrin, is a selective reversal agent for aminosteroid NMBAs such as rocuronium. Its mechanism of encapsulating steroidal neuromuscular blocking molecules raises concerns about potential interactions with other steroidal drugs, including perioperatively used corticosteroids.
Corticosteroids are commonly administered in the perioperative period for their antiemetic, analgesic, and anti-inflammatory effects. Dexamethasone is widely accepted for postoperative nausea and vomiting prophylaxis, while methylprednisolone is preferred for its rapid anti-inflammatory effect. Previous studies have suggested that the structural similarity of corticosteroids to rocuronium may interfere with sugammadex binding, but the available evidence is conflicting, and data on methylprednisolone remain limited. In a prior study, methylprednisolone was shown to prolong sugammadex reversal time slightly, but no direct comparison with another corticosteroid was performed.
This randomized controlled trial is designed to compare the effects of methylprednisolone and dexamethasone on sugammadex reversal time in pediatric patients undergoing adenoidectomy and/or tonsillectomy. The study will assess whether methylprednisolone has a stronger interaction with sugammadex compared with dexamethasone, leading to prolonged recovery from rocuronium block. Secondary outcomes will include postoperative pain, nausea and vomiting, extubation time, and adverse events. The results may provide clinically relevant evidence regarding the choice of corticosteroid in pediatric anesthesia when sugammadex is used for neuromuscular block reversal.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone | Experimental | Patients will receive intravenous methylprednisolone 1 mg/kg at the induction of anesthesia. |
|
| Dexamethasone | Experimental | Patients will receive intravenous dexamethasone 0.2 mg/kg at the induction of anesthesia |
|
| Control | Placebo Comparator | Patients will receive 5 ml of intravenous normal saline at the induction of anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methyl Prednisolone (MP) | Drug | Dose: 1 mg/kg IV Timing: at the induction of anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to recovery of neuromuscular function (normalised train-of-four ratio ≥ 0.9) after sugammadex injection | Time from intravenous sugammadex administration to restoration of normalised train-of-four ratio ≥ 0.9, measured by quantitative acceleromyography at the adductor pollicis muscle under standardized monitoring conditions. | From intravenous administration of sugammadex until achievement of normalized TOF ratio ≥ 0.9 (in seconds). |
| Measure | Description | Time Frame |
|---|---|---|
| Extubation time | Time from intravenous sugammadex administration to removal of the endotracheal tube, recorded by anesthesia staff. | From intravenous administration of sugammadex until tracheal extubation (in minutes). |
| Postoperative pain score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konya City Hospital | Konya | Karatay | 42050 | Turkey (Türkiye) | ||
| Bezmialem Vakıf Univerisity Dragos Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26771267 | 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. | |
| 27028777 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055191 | Delayed Emergence from Anesthesia |
| D000377 | Agnosia |
| D020250 | Postoperative Nausea and Vomiting |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dexamethasone (0.2 mg/kg) | Drug | Dose: 0.2 mg/kg IV (glucocorticoid equivalent to 1 mg/kg methylprednisolone) Timing: at the induction of anesthesia |
|
| Saline (0.9% NaCl) | Drug | Dose: 5 ml IV Timing: at the induction of anesthesia |
|
Faces Pain Scale-Revised (0-10) assessed at predefined time points; higher scores indicate more pain.
| At 2 hours after surgery. |
| Postoperative Nausea Severity | Baxter Retching Faces (0-10) pictorial scale; higher scores indicate more severe nausea/retching. | At 2 hours after surgery. |
| Istanbul |
| Turkey (Türkiye) |
| 21565530 | 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. |
| 40659442 | 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. |
| 22798534 | 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. |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |
| D010146 | Pain |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |