The Relationship Between the Degree of Neuromuscular Blockade and the Conditions of Laryngeal Mask Ventilation: A Prospective Randomized Double-Blind Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 96
- 主要终点
- Oropharyngeal Leak Pressure (OLP)
研究概览
简要总结
This prospective, randomized, double-blind study aims to evaluate the effect of different degrees of neuromuscular blockade on the performance of a video laryngeal mask airway (LMA) during general anesthesia. Participants will be randomly assigned to receive rocuronium at 0, 0.3, or 0.6 mg/kg, corresponding to 0, 1, or 2 times the ED95, respectively. The primary outcome is oropharyngeal leak pressure measured after LMA insertion. Secondary outcomes include LMA insertion conditions, insertion time and number of attempts, laryngeal view, respiratory parameters, and postoperative airway-related complications.
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
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for elective surgery under general anesthesia with a video
- •laryngeal mask airway
- •Expected duration of surgery less than 3 hours
- •Surgery performed in the supine position
- •Provision of written informed consent
排除标准
- •Symptoms or signs of upper respiratory tract infection
- •Increased risk of pulmonary aspiration
- •Anticipated difficult airway
- •Limited mouth opening (<3 cm)
- •Limited head or neck movement
- •Mallampati class IV
- •Body mass index ≥35 kg/m²
研究组 & 干预措施
0 × ED95 Group
Participants receive rocuronium 0 mg/kg (0 × ED95) before video LMA insertion.
干预措施: Normal Saline (Rocuronium 0 mg/kg) (Other)
1 × ED95 Group
Participants receive rocuronium 0.3 mg/kg (1 × ED95) before video LMA insertion.
干预措施: Rocuronium 0.3 mg/kg (Drug)
2 × ED95 Group
Participants receive rocuronium 0.6 mg/kg (2 × ED95) before video LMA insertion.
干预措施: Rocuronium 0.6 mg/kg (Drug)
结局指标
主要结局
Oropharyngeal Leak Pressure (OLP)
时间窗: 5 minutes after successful video LMA insertion
Oropharyngeal leak pressure will be measured 5 minutes after successful video LMA insertion and compared among the three neuromuscular blockade groups. OLP is expressed in cmH2O.
次要结局
- Oropharyngeal Leak Pressure at Later Time Points(15 and 30 minutes after successful video LMA insertion)
- Number of LMA Insertion Attempts(During anesthetic induction before surgery, assessed for up to 5 minutes)
- LMA Insertion Time(During anesthetic induction before surgery, assessed for up to 5 minutes)
- Laryngeal View Grade(Immediately after successful video LMA insertion)
- Neuromuscular Blockade at LMA Insertion(Immediately before video LMA insertion)
- Number of Participants With Sore Throat, Hoarseness, and Dysphagia(Postoperatively in the PACU and at 24 hours after surgery)
研究者
Seok Kyeong Oh
Professor of Anesthesiology
Korea University Guro Hospital