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NCT Number: NCT07175623

Methylprednisolone vs Dexamethasone Interaction With Sugammadex in Pediatric Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methyl Prednisolone (MP)

Drug

Dose: 1 mg/kg IV

Timing: at the induction of anesthesia

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

Primary outcomes

  1. Time to recovery of neuromuscular function (normalised train-of-four ratio ≥ 0.9) after sugammadex injection

    Time frame: 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 outcomes

  1. Extubation time

    Time frame: 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.

  2. Postoperative pain score

    Time frame: At 2 hours after surgery.

    Faces Pain Scale-Revised (0-10) assessed at predefined time points; higher scores indicate more pain.

  3. Postoperative Nausea Severity

    Time frame: At 2 hours after surgery.

    Baxter Retching Faces (0-10) pictorial scale; higher scores indicate more severe nausea/retching.

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

Comparison of the Effects of the Interaction of Methylprednisolone and Dexamethasone With Sugammadex on Rocuronium Reversal Time, Postoperative Pain, and Nausea in Pediatric Patients: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 16, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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