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临床试验/NCT02809378
NCT02809378已完成4 期

The Effects of Anesthetic Techniques and Palonosetron Administration on the Incidence of Postoperative Nausea and Vomiting in the Women Patients Undergoing Thyroidectomy

Ajou University School of Medicine1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年6月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
incidence of postoperative nausea and vomiting

研究概览

简要总结

The incidence of postoperative nausea and vomiting (PONV) after thyroidectomy have been shown to be relatively high compared other surgeries, with a reported incidence 65-75 %. PONV may increase patient discomfort, delay patient discharge, and increase the cost of patient care, the risk of postoperative bleeding which may potentially cause airway obstruction.

It is reported that the maintenance of anesthesia with propofol-remifentanil or sevoflurane-propofol-remifentanil decreased the incidence of PONV compared sevoflurane alone, but failed to demonstrate the decreased incidence of PONV in 6-24 hr postoperative period in patients undergoing thyroidectomy. Administration of Palonosetron, newly developed 5-HT3 antagonists with long half life (48 hrs) may decrease the incidence of PONV particularly during this period.

The purpose of this study was to evaluate and compare the incidence of PONV after thyroidectomy with three different anesthetic methods, sevoflurane or sevoflurane-propofol-remifentanil or sevoflurane-propofol-remifentanil-palonosetron in woman patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • patients undergoing thyroidectomy euthyroid status American Society of Anesthesiology Physical status 1,2

排除标准

  • Ideal body weight >130% gastrointestinal disease prior administration of anti-emetics (24hr)

研究组 & 干预措施

Sevoflurane, remifentanil, propofol, and palonosetron

Experimental

anesthesia induction and maintenance with remifentanil, propofol and sevoflurane(1.6-2.5 vol%), and palonosetron 75 ug administration prior to anesthesia induction.

干预措施: sevoflurane (Drug)

Sevoflurane

Experimental

anesthesia induction with pentothal sodium (4-5 mg/kg), maintenance with sevoflurane(1.6-2.5 vol%)

干预措施: sevoflurane (Drug)

Sevoflurane

Experimental

anesthesia induction with pentothal sodium (4-5 mg/kg), maintenance with sevoflurane(1.6-2.5 vol%)

干预措施: pentothal sodium (Drug)

sevoflurane, remifentanil, and propofol

Experimental

anesthesia induction and maintenance with remifentanil, propofol and sevoflurane(1.6-2.5 vol%)

干预措施: sevoflurane (Drug)

sevoflurane, remifentanil, and propofol

Experimental

anesthesia induction and maintenance with remifentanil, propofol and sevoflurane(1.6-2.5 vol%)

干预措施: remifentanil (Drug)

sevoflurane, remifentanil, and propofol

Experimental

anesthesia induction and maintenance with remifentanil, propofol and sevoflurane(1.6-2.5 vol%)

干预措施: propofol (Drug)

Sevoflurane, remifentanil, propofol, and palonosetron

Experimental

anesthesia induction and maintenance with remifentanil, propofol and sevoflurane(1.6-2.5 vol%), and palonosetron 75 ug administration prior to anesthesia induction.

干预措施: Palonosetron (Drug)

Sevoflurane, remifentanil, propofol, and palonosetron

Experimental

anesthesia induction and maintenance with remifentanil, propofol and sevoflurane(1.6-2.5 vol%), and palonosetron 75 ug administration prior to anesthesia induction.

干预措施: remifentanil (Drug)

Sevoflurane, remifentanil, propofol, and palonosetron

Experimental

anesthesia induction and maintenance with remifentanil, propofol and sevoflurane(1.6-2.5 vol%), and palonosetron 75 ug administration prior to anesthesia induction.

干预措施: propofol (Drug)

结局指标

主要结局

incidence of postoperative nausea and vomiting

时间窗: 24 hour postoperative

次要结局

  • incidence of postoperative nausea and vomiting(48 hour postoperative)

研究者

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

DAE HEE KIM

Assistant Professor

Ajou University School of Medicine

研究点 (1)

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