Methylprednisolone vs Dexamethasone: Effects on Sugammadex Reversal, Pain, and Nausea in Adults

NCT07187037 | Not Yet Recruiting

• 1 other identifier: AEŞH-EK-2025- 100
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to compare the effects of intravenous methylprednisolone and dexamethasone on the reversal time of rocuronium by sugammadex in adult patients undergoing elective septoplasty or rhinoplasty. The primary outcome is the time from sugammadex administration to recovery of a train-of-four (TOF) ratio of 0.9. Secondary outcomes include extubation time, postoperative nausea and vomiting (PONV), pain scores, complications in the post-anesthesia care unit (PACU), and intraoperative hemodynamic parameters. The study will provide new evidence on whether perioperative corticosteroid choice modifies the efficacy of sugammadex and influences postoperative recovery.

Conditions

Neuromuscular Block, Residual; Pain; Postoperative Nausea

Keywords

sugammadex; dexamethasone; methylprednisolone; postoperative nausea; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Reversal Time

  The interval in seconds between intravenous administration of sugammadex (2 mg/kg) and achievement of a normalised train-of-four ratio ≥0.9 measured at the adductor pollicis muscle using acceleromyography.

  Perioperative period (Immediately after sugammadex administration until achievement of a normalised train-of-four ratio ≥0.9, measured in seconds)

Secondary Outcomes (3)

• Extubation time

  Perioperative period (from sugammadex administration until tracheal extubation, in minutes)

• Postoperative pain scores

  At 2 hours postoperatively

• Postoperative nausea and vomiting (PONV) incidence and severity

  At 2 hours postoperatively

Study Arms (2)

Methylprednisolone Group

ACTIVE COMPARATOR

Patients will receive intravenous methylprednisolone 1 mg/kg diluted in 5 mL saline, administered at anesthesia induction. Neuromuscular blockade will be achieved with rocuronium. Reversal will be performed with sugammadex 2 mg/kg at reappearance of the second twitch in train of four monitoring.

Drug: Methylprednisolone (MP)

Dexamethasone Group

ACTIVE COMPARATOR

Patients will receive intravenous dexamethasone 0.2 mg/kg diluted in 5 mL saline, administered at anesthesia induction. Neuromuscular blockade will be achieved with rocuronium. Reversal will be performed with sugammadex 2 mg/kg at reappearance of second twitch in train of four monitoring

Drug: Dexamethasone

Interventions

Methylprednisolone (MP) DRUG

Methylprednisolone 1 mg/kg IV (diluted to 5 mL with saline) will be administered at induction of anesthesia. Neuromuscular blockade will be achieved with rocuronium. Reversal will be performed with sugammadex 2 mg/kg IV at the reappearance of the second twitch in train of four monitoring.

Methylprednisolone Group

Dexamethasone DRUG

Dexamethasone 0.2 mg/kg IV (diluted to 5 mL with saline) will be administered at induction of anesthesia. Neuromuscular blockade will be achieved with rocuronium. Reversal will be performed with sugammadex 2 mg/kg IV at the reappearance of second twitch in train of four monitoring.

Dexamethasone Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18-65 years
• American Society of Anesthesiologists (ASA) physical status I-II
• Scheduled for elective septoplasty or rhinoplasty under general anesthesia
• Written informed consent obtained

You may not qualify if:

• ASA physical status ≥ III
• Emergency surgery
• Known allergy or contraindication to rocuronium, sugammadex, or corticosteroids
• Chronic or recent (within 3 months) systemic corticosteroid therapy
• Concomitant use of drugs that may interact with sugammadex (e.g., toremifene, flucloxacillin, fusidic acid)
• Neuromuscular disorders (e.g., myasthenia gravis, muscular dystrophy)
• Significant hepatic, renal, respiratory, or cardiac dysfunction
• Anticipated difficult airway or history of difficult intubation
• Nasopharyngeal or oropharyngeal anomalies interfering with airway management
• Developmental or cognitive impairment interfering with informed consent or cooperation

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya City Hospital

Karatay, Konya, 42050, Turkey (Türkiye)

Location

Related Publications (2)

• Zwiers A, van den Heuvel M, Smeets J, Rutherford S. Assessment of the potential for displacement interactions with sugammadex: a pharmacokinetic-pharmacodynamic modelling approach. Clin Drug Investig. 2011;31(2):101-11. doi: 10.2165/11584730-000000000-00000.

  PMID: 21067251 BACKGROUND

• Fortier LP, McKeen D, Turner K, de Medicis E, Warriner B, Jones PM, Chaput A, Pouliot JF, Galarneau A. The RECITE Study: A Canadian Prospective, Multicenter Study of the Incidence and Severity of Residual Neuromuscular Blockade. Anesth Analg. 2015 Aug;121(2):366-72. doi: 10.1213/ANE.0000000000000757.

  PMID: 25902322 BACKGROUND

MeSH Terms

Conditions

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

Interventions

Methylprednisolone; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

MUSTAFA BÜYÜKCAVLAK, MD

CONTACT

+905064733392; mustafabcavlak@gmail.com

Study Design

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

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 22, 2025
• Study Start: October 1, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)