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Methylprednisolone vs Dexamethasone Interaction With Sugammadex in Pediatric Patients

NCT07175623 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-29

No results posted yet for this study

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.

Conditions

  • Neuromuscular Block, Residual
  • Pain Management
  • Postoperative Nausea

Interventions

DRUG

Methyl Prednisolone (MP)

Dose: 1 mg/kg IV Timing: at the induction of anesthesia

DRUG

Dexamethasone (0.2 mg/kg)

Dose: 0.2 mg/kg IV (glucocorticoid equivalent to 1 mg/kg methylprednisolone) Timing: at the induction of anesthesia

DRUG

Saline (0.9% NaCl)

Dose: 5 ml IV Timing: at the induction of anesthesia

Sponsors & Collaborators

  • Konya City Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-16
Primary Completion
2025-12-20
Completion
2025-12-20

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07175623 on ClinicalTrials.gov