Comparison of the Effects of the Interaction of Methylprednisolone and Dexamethasone With Sugammadex on Rocuronium Reversal Time, Postoperative Pain, and Nausea in Adult Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Reversal Time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Methylprednisolone Group
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.
干预措施: Methylprednisolone (MP) (Drug)
Dexamethasone Group
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
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Reversal Time
时间窗: Perioperative period (Immediately after sugammadex administration until achievement of a normalised train-of-four ratio ≥0.9, measured in seconds)
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.
次要结局
- Postoperative nausea and vomiting (PONV) incidence and severity(At 2 hours postoperatively)
- Postoperative pain scores(At 2 hours postoperatively)
- Extubation time(Perioperative period (from sugammadex administration until tracheal extubation, in minutes))
研究者
MUSTAFA BÜYÜKCAVLAK
Specialist in Anesthesiology and Intensive Care
Konya City Hospital