Methylprednisolone vs Dexamethasone Interaction With Sugammadex in Pediatric Patients

NCT07175623 | Completed

• 1 other identifier: 12-5/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Neuromuscular Block, Residual; Pain Management; Postoperative Nausea

Keywords

Sugammadex; Methylprednisolone; Dexamethasone; Postoperative pain; Postoperative nausea; Pediatric Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (3)

• Extubation time

  From intravenous administration of sugammadex until tracheal extubation (in minutes).

• Postoperative pain score

  At 2 hours after surgery.

• Postoperative Nausea Severity

  At 2 hours after surgery.

Study Arms (3)

Methylprednisolone

EXPERIMENTAL

Patients will receive intravenous methylprednisolone 1 mg/kg at the induction of anesthesia.

Drug: Methyl Prednisolone (MP)

Dexamethasone

EXPERIMENTAL

Patients will receive intravenous dexamethasone 0.2 mg/kg at the induction of anesthesia

Drug: Dexamethasone (0.2 mg/kg)

Control

PLACEBO COMPARATOR

Patients will receive 5 ml of intravenous normal saline at the induction of anesthesia

Drug: Saline (0.9% NaCl)

Interventions

Methyl Prednisolone (MP) DRUG

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

Methylprednisolone

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

Dexamethasone

Saline (0.9% NaCl) DRUG

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

Control

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 5-12 years
• American Society of Anesthesiologists (ASA) physical status I-II

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (2)

Konya City Hospital

Konya, Karatay, 42050, Turkey (Türkiye)

Location

Bezmialem Vakıf Univerisity Dragos Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 26771267 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.

  PMID: 27028777 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.

  PMID: 21565530 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.

  PMID: 40659442 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.

  PMID: 22798534 BACKGROUND

MeSH Terms

Conditions

Delayed Emergence from Anesthesia; Agnosia; Postoperative Nausea and Vomiting; Pain, Postoperative

Interventions

Dexamethasone; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting; Pain

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Anesthesiology and Intensive Care, Principal Investigator

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 16, 2025
• Study Start: September 16, 2025
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)