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临床试验/NCT03218124
NCT03218124Unknown不适用

Optimal Effect Site Remifentanil Concentration for Smooth Extubation After Thyroid Surgery

University of Cagliari1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Cough

研究概览

简要总结

The study is aimed at determining the remifentanil effect site concentration suppressing the cough at extubation after surgical thyroidectomy, performed under remifentanil/desflurane based general anesthesia, expressed as median and 95th percentile effective dose.

Possible hemodynamic instability, respiratory depression or prolongation of awakening time are also sought.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

盲法说明

Patient under general anesthesia unaware of the effect site concentration of remifentanil before extubation

入排标准

年龄范围
18 Years 至 67 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18<age<67
  • •6 hrs fasting
  • •American society of anesthesiology (ASA) Physical Status I o II
  • •Informed consent

排除标准

  • •Absence of inclusion criteria
  • •Use of cough suppressors, angiotensin converting enzyme-inhibitors, sedatives 4 weeks before surgery
  • •Arhythmia, pacemaker or unstable cardiovascular disease
  • •Hepatic or renal failure
  • •Anticipated difficulty in airways management
  • •Chronic obstructive pulmonary disease (COPD), Asthma, increased risk for inhalation, airway infection in the previous 4 weeks;
  • •Obesity (BMI >35)
  • •Pregnancy
  • •Hypersensitivity to drugs administered for the study

研究组 & 干预措施

remifentanil

Experimental

After skin suture, a predetermined Effect site remifentanil concentration will be achieved. Starting from 1.5 ng/ml in the first patient and increased or decreased by 0.2 ng/ml intervals based on the previous patient response: up if cough present, down otherwise ("Dixon's up and down" method).

干预措施: Remifentanil Effect site concentration (Other)

结局指标

主要结局

Cough

时间窗: 15 minutes after surgery

Any episode of sudden and violent abdominal contraction interrupting normal quite spontaneous or assisted ventilation would be accounted as "cough" and defines non-smooth extubation

次要结局

  • Hemodynamics 1(15 minutes after surgery)
  • Hemodynamics 2(15 minutes after surgery)
  • Respiratory outcome 1(15 minutes after surgery)
  • Respiratory outcome 2(15 minutes after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Gabriele Finco

Professor of Anesthesiology and Intensive Care

University of Cagliari

研究点 (1)

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