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

Официальное название

Comparison of the Effects of the Interaction of Methylprednisolone and Dexamethasone With Sugammadex on Rocuronium Reversal Time, Postoperative Pain, and Nausea in Adult Patients

Обзор

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.

Подробное описание

Neuromuscular blockade with rocuronium is routinely reversed with sugammadex. Corticosteroids such as methylprednisolone and dexamethasone are frequently used perioperatively for their anti-inflammatory and antiemetic effects. However, possible pharmacological interactions between corticosteroids and sugammadex remain unclear and may affect reversal time.

This prospective, randomized, parallel-group clinical trial will enroll adult ASA I-II patients scheduled for elective septoplasty or rhinoplasty. Patients will be randomized to receive either methylprednisolone (1 mg/kg IV) or dexamethasone (0.2 mg/kg IV) at induction of anesthesia. Rocuronium will be administered for neuromuscular blockade, and sugammadex (2 mg/kg IV) will be given at the reappearance of the second twitch in TOF monitoring. Neuromuscular recovery will be continuously assessed with acceleromyography at the adductor pollicis muscle.

The primary outcome is the time interval from sugammadex injection to a TOF ratio of 0.9.

Secondary outcomes include extubation time, total rocuronium consumption, incidence and severity of PONV (assessed by VAS-B at 0, 30, 60, and 120 minutes in PACU), postoperative pain (VAS-A at the same time points), PACU complications (desaturation, stridor, severe cough), and intraoperative hemodynamic variables.

All anesthetic procedures will be standardized, and outcome assessors and statisticians will be blinded to group allocation. The results of this trial may guide perioperative steroid selection in patients receiving sugammadex reversal and help optimize postoperative recovery.

Вмешательства

• Препарат Methylprednisolone (MP)
  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.
• Препарат Dexamethasone
  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.

Первичные конечные точки

• Reversal Time [Срок оценки: Perioperative period (Immediately after sugammadex administration until achievement of a normalised train-of-four ratio ≥0.9, measured in seconds)]

Вторичные конечные точки (3)

• Extubation time [Срок оценки: Perioperative period (from sugammadex administration until tracheal extubation, in minutes)]
• Postoperative pain scores [Срок оценки: At 2 hours postoperatively]
• Postoperative nausea and vomiting (PONV) incidence and severity [Срок оценки: At 2 hours postoperatively]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

Turkey (Türkiye) · 1 центр

• Konya City Hospital — Karatay

Публикации

• 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
• 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

Идентификаторы

NCT: NCT07187037 · AEŞH-EK-2025- 100

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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