Minimal Optimal Dose of Sugammadex in Elective Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluate the recovery time of the ratio 0.9.
研究概览
简要总结
Time of appearance of TOF Ratio >0,9 with different doses of Sugammadex
详细描述
Design: monocentric, prospective, controlled, randomized, double-blind study Inclusion criteria: women and men> 18 years old, elective surgery, BMI <30, patients giving consent to free and informed participation in writing;
Exclusion criteria:
- minor patients;
- Patients refusing to sign the consent;
- Patients included in another protocol within 3 months;
- Pregnant or lactating patients;
- Patients with a history of allergy to Sugammadex;
- Patients with known neuromuscular disease;
- Patients with renal or hepatic impairment.
Course of the study :
- 40 patients will be recruited at the time of the anesthesia consultation and randomized to double blind in 8 groups (the day before surgery)
- All patients will benefit from general anesthesia. Anesthetic management
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •women and men> 18 years of age Elective Surgery BMI <30, patients who gave consent to free and informed participation in writing
排除标准
- •minor patients;
- •patients refusing to sign consent;
- •patients included in another protocol within 3 months;
- •pregnant or nursing patients;
- •patients with a history of allergy to Sugammadex;
- •patients with known neuromuscular disease
- •patients with renal or hepatic impairment.
研究组 & 干预措施
Dose of 0mg/kg TOF1
干预措施: Sugammadex Injection [Bridion] (Drug)
Dose of 0mg/kg TOF2
干预措施: Sugammadex Injection [Bridion] (Drug)
Dose of 0 ,5mg/kg TOF1
干预措施: Sugammadex Injection [Bridion] (Drug)
Dose of 0,5mg/kg TOF2
干预措施: Sugammadex Injection [Bridion] (Drug)
Dose of 1mg/kg TOF1
干预措施: Sugammadex Injection [Bridion] (Drug)
Dose of 1mg/kg TOF2
干预措施: Sugammadex Injection [Bridion] (Drug)
Dose of 2mg/kg TOF1
干预措施: Sugammadex Injection [Bridion] (Drug)
Dose of 2mg/kg TOF2
干预措施: Sugammadex Injection [Bridion] (Drug)
结局指标
主要结局
Evaluate the recovery time of the ratio 0.9.
时间窗: 1 hour
Evaluate the recovery time of the ratio 0.9.
次要结局
- Evaluate the four-to-four ratio <0.7 after total recovery.(1 hour)
- Watch time at the recovery room.(4 hours)
- Time of appearance of 4 responses to the TOF(1 hour)
