Neuromuscular Block, Residual, Pain Management, Postoperative Nausea
Conditions
Keywords
Sugammadex, Methylprednisolone, Dexamethasone, Postoperative pain, Postoperative nausea, Pediatric Anesthesia
Brief 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.
Detailed description
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.
Interventions
Dose: 1 mg/kg IV Timing: at the induction of anesthesia
Dose: 0.2 mg/kg IV (glucocorticoid equivalent to 1 mg/kg methylprednisolone) Timing: at the induction of anesthesia
DRUGSaline (0.9% NaCl)
Dose: 5 ml IV Timing: at the induction of anesthesia
Sponsors
Konya City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 5-12 years * American Society of Anesthesiologists (ASA) physical status I-II
Exclusion criteria
* ASA physical status ≥ III * Emergency surgery * Known allergy or contraindication to neuromuscular blocking agents, sugammadex, or corticosteroids * Chronic or recent systemic corticosteroid use (within the last 3 months) * Neuromuscular disorders (e.g., muscular dystrophy, myasthenia gravis) * Severe hepatic or renal dysfunction * Significant respiratory or cardiac disease * Anticipated difficult airway or history of difficult intubation * Developmental delay or craniofacial anomalies affecting airway management * Refusal of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to recovery of neuromuscular function (normalised train-of-four ratio ≥ 0.9) after sugammadex injection | From intravenous administration of sugammadex until achievement of normalized TOF ratio ≥ 0.9 (in seconds). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Extubation time | From intravenous administration of sugammadex until tracheal extubation (in minutes). | Time from intravenous sugammadex administration to removal of the endotracheal tube, recorded by anesthesia staff. |
| Postoperative pain score | At 2 hours after surgery. | Faces Pain Scale-Revised (0-10) assessed at predefined time points; higher scores indicate more pain. |
| Postoperative Nausea Severity | At 2 hours after surgery. | Baxter Retching Faces (0-10) pictorial scale; higher scores indicate more severe nausea/retching. |
Countries
Turkey (Türkiye)
Outcome results
None listed