Sugammadex-Induced Clenching During Neuromuscular Blockade Reversal
报名条件（概要）
- 年龄：19 Years – 70 Years
- 性别：不限
- 健康志愿者：接受
完整入排标准请以官方页面为准。
开展国家/地区
South Korea
药品与企业信息
其他名称：S1
Participants receive 1 mg/kg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade.
其他名称：S2
Participants receive 2 mg/kg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade.
其他名称：S4
Participants receive 4 mg/kg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade.
其他名称：PG
Participants receive pyridostigmine 0.2 mg/kg and glycopyrrolate 0.01 mg/kg intravenously for reversal of rocuronium-induced neuromuscular blockade.
研发企业
试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。
研究简介（原文）
Study Objective: This study aims to evaluate the incidence, severity, and risk factors of sugammadex-induced mouth clenching during neuromuscular blockade (NMB) reversal in adult surgical patients. Study Design: This prospective, randomized, double-blind, controlled clinical trial enrolls adult patients (ASA physical status I-II, aged 19-70 years) undergoing elective surgery under general anesthesia with rocuronium. Patients will be randomized into four groups to receive either sugammadex at doses of 1 mg/kg, 2 mg/kg, or 4 mg/kg, or a combination of pyridostigmine and glycopyrrolate. Primary Outcome: The primary outcome is the incidence of clenching within 10 minutes after NMB reversal, assessed by clinical observation, masseter EMG, and airway pressure changes, using a novel five-grade severity scale. Secondary Outcomes: Secondary outcomes include the severity of clenching, time to TOF ratio ≥0.9, BIS values at clenching onset, complications, and identification of risk factors such as dose, sex, BIS, age, BMI, and rocuronium dose. Significance: This study seeks to improve perioperative safety by identifying modifiable risk factors and informing dose adjustments or alternative reversal strategies to prevent sugammadex-induced clenching, particularly in high-risk populations.
适应症
主动联系研究团队
这项试验目前在中国大陆没有研究中心
这种情况下，直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药／扩展准入（由主治医生一同提出），或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。
查看完整申请路径与成功率说明 →总联系人（申办方／研究总部）
- Cheol Lee, MD, PhDironyii70@gmail.com82-10-6613-1252
研究中心联系方式
- Wonkwang University hospitalIksan，Jeonbuk-do，South Korea
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英文版（发给研究团队）
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Sugammadex-Induced Clenching During Neuromuscular Blockade Reversal ClinicalTrials.gov Identifier: NCT06962007 Sponsor: Wonkwang University Hospital Investigational product: Sugammadex 1 mg/kg Group, Sugammadex 2 mg/kg Group, Sugammadex 4 mg/kg Group, Pyridostigmine/Glycopyrrolate Group About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照（供您核对）
尊敬的研究团队： 我是一位来自中国的患者，希望咨询参加以下临床试验的可能： 研究名称：Sugammadex-Induced Clenching During Neuromuscular Blockade Reversal 试验编号：NCT06962007 申办方：Wonkwang University Hospital 研究药物：Sugammadex 1 mg/kg Group、Sugammadex 2 mg/kg Group、Sugammadex 4 mg/kg Group、Pyridostigmine/Glycopyrrolate Group 我的基本情况： - 年龄：（请填写） - 性别：（请填写） - 确诊疾病与分期：（请填写） - 基因／标志物检测：暂无 - 既往及当前治疗：（请填写） - 体能状态（ECOG）：未评估 - 目前所在城市：中国 - 可前往范围：（请填写） 想请教三个问题： 1. 我是否可能符合本研究的入组标准？ 2. 哪个中心对我最方便可行？能否远程预筛？ 3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？ 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 （您的姓名） （您的邮箱／带国际区号的电话）
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下一步怎么做？
- 把本页信息带给您的主治医生，评估是否适合参加。
- 点击下方按钮打开官方注册页，查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。