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临床试验/NCT02252419
NCT02252419Unknown不适用

Combined Effect of Preoperative Dexamethasone and Intraoperative Paracetamol on Postoperative Sore Throat for Patients Undergoing Urologic Surgery

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
242
试验地点
1
主要终点
Postoperative sore throat

研究概览

简要总结

The investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the prevention of postoperative sore throat.

详细描述

The postoperative sore throat is a common complication after the general anesthesia which decreases the quality of life. Dexamethasone is known to effective for the prevention of postoperative sore throat. The combined effect of the dexamethasone and paracetamol for postoperative sore throat, however, is not investigated.

The investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the prevention of postoperative sore throat.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for urologic surgery under general anesthesia
  • ASA I-III

排除标准

  • Patients with recent sore throat
  • Patients with neck surgery
  • Patients with anticipated difficult airway
  • Patients with Mallampati grade 3
  • Patients with severe cardiovascular or pulmonary disease
  • Patients with allergic history to dexamethasone or paracetamol
  • Patients with liver function disorder
  • Patients with liver disease

研究组 & 干预措施

Dexamethasone

Active Comparator

Dexamethasone will be administered 30 minutes before the anesthetic induction.

干预措施: Dexamethasone (Drug)

Dexamethasone+ Paracetamol (DP)

Experimental

Dexamethasone will be administered 30 minutes before the anesthetic induction. Paracetamol will be administered at the end of the surgery.

干预措施: Dexamethasone (Drug)

Dexamethasone+ Paracetamol (DP)

Experimental

Dexamethasone will be administered 30 minutes before the anesthetic induction. Paracetamol will be administered at the end of the surgery.

干预措施: Paracetamol (Drug)

结局指标

主要结局

Postoperative sore throat

时间窗: 1 hour postoperatively

Postoperative sore throat after 1 hour postoperatively will be measured (0:none, 1:mild, 2:moderate, 3:severe)

次要结局

  • Postoperative pain(0, 1, 6, 24 hour postoperatively)
  • Vomiting(0, 1, 6, 24 hour postoperatively)
  • Postoperative sore throat degree(0, 1, 6, 24 hour postoperatively)
  • Nausea(0, 1, 6, 24 hour postoperatively)
  • Somnolence(0, 1, 6, 24 hour postoperatively)
  • Headache(0, 1, 6, 24 hour postoperatively)
  • Hoarseness(0, 1, 6, 24 hour postoperatively)
  • Dysphagia(0, 1, 6, 24 hour postoperatively)
  • Postoperative sore throat(0, 6, 24 hour postoperatively)
  • Shivering(0, 1, 6, 24 hour postoperatively)
  • Analgesics(0, 1, 6, 24 hour postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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