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临床试验/NCT03515694
NCT03515694已完成4 期

Minimal Optimal Dose of Sugammadex in Elective Surgery

Erasme University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年4月3日最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

干预措施: Sugammadex Injection [Bridion] (Drug)

Dose of 0mg/kg TOF2

Placebo Comparator

干预措施: Sugammadex Injection [Bridion] (Drug)

Dose of 0 ,5mg/kg TOF1

Experimental

干预措施: Sugammadex Injection [Bridion] (Drug)

Dose of 0,5mg/kg TOF2

Active Comparator

干预措施: Sugammadex Injection [Bridion] (Drug)

Dose of 1mg/kg TOF1

Experimental

干预措施: Sugammadex Injection [Bridion] (Drug)

Dose of 1mg/kg TOF2

Active Comparator

干预措施: Sugammadex Injection [Bridion] (Drug)

Dose of 2mg/kg TOF1

Experimental

干预措施: Sugammadex Injection [Bridion] (Drug)

Dose of 2mg/kg TOF2

Active Comparator

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)

研究者

发起方
Erasme University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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