Methylprednisolone vs Dexamethasone Interaction With Sugammadex in Pediatric Patients

NCT ID: NCT07175623

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-16
• Study Completion Date: 2025-12-20

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.

Conditions

Neuromuscular Block, Residual; Pain Management; Postoperative Nausea

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Methylprednisolone

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

Group Type: EXPERIMENTAL

Methyl Prednisolone (MP)

Intervention Type: DRUG

Dose: 1 mg/kg IV

Timing: at the induction of anesthesia

Dexamethasone

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

Group Type: EXPERIMENTAL

Dexamethasone (0.2 mg/kg)

Intervention Type: DRUG

Dose: 0.2 mg/kg IV (glucocorticoid equivalent to 1 mg/kg methylprednisolone)

Timing: at the induction of anesthesia

Control

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

Group Type: PLACEBO_COMPARATOR

Saline (0.9% NaCl)

Intervention Type: DRUG

Dose: 5 ml IV

Timing: at the induction of anesthesia

Interventions

Methyl Prednisolone (MP)

Dose: 1 mg/kg IV

Timing: at the induction of anesthesia

Intervention Type: 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

Intervention Type: DRUG

Saline (0.9% NaCl)

Dose: 5 ml IV

Timing: at the induction of anesthesia

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Konya City Hospital

OTHER

Sponsor Role: lead

Responsible Party

MUSTAFA BÜYÜKCAVLAK

Specialist in Anesthesiology and Intensive Care, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Konya City Hospital

Konya, Karatay, Turkey (Türkiye)

Bezmialem Vakıf Univerisity Dragos Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 26771267 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27028777 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21565530 (View on PubMed)

. Gold SJA, Harper NJN. The place of sugammadex in anaesthesia practice. Trends Anaesth Crit Care 2012; 2: 4-9.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 40659442 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22798534 (View on PubMed)

Other Identifiers

12-5/2025

Identifier Type: -

Identifier Source: org_study_id