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临床试验/NCT04742660
NCT04742660已完成不适用

The Effect of Administration of Glycyrrhizin During Induction Period on the Occurrence of Postoperative Nausea and Vomiting After Breast Surgery

Konkuk University Medical Center1 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2021年5月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
224
试验地点
1
主要终点
the incidence of postoperative nausea and vomiting (PONV)

研究概览

简要总结

The investigators investigate the association between the administration of glycyrrhizin during induction of general anesthesia and the occurrence of postoperative nausea and vomiting (PONV) in patients undergo breast surgery

详细描述

Postoperative nausea and vomiting (PONV) is one of a common complication after general anesthesia with 30-50% of incidence, increased up to 80% in high risk group. The risk factors of PONV include women population, the previous history of PONV, motion sickness in usual life, non-smoker, exposure to inhalants, perioperative opioid and laparoscopic surgery. Women population is a strong risk factor of PONV. Although perioperative management of PONV based on a guideline has been done in a lot of medical centers worldwide, the incidence of PONV is still reported relatively high.

The main ingredient of Glycyrrhizin is liquorice which has been used as antispasmodics, antiemetics or treatment for gastric ulcer in oriental medicine. Utilizing these effects of liquorice, the investigators investigate whether the addition of glycyrrhzin to conventional antiemetics is effective to decrease the incidence of PONV and improvement of severity of PONV.

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)

盲法说明

Participants are blinded to allocated groups. Outcomes assessors are blinded to which group participants are assigned.

入排标准

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

入选标准

  • participants scheduled to undergo breast surgery aged 20 and above

排除标准

  • aldosteronism
  • electrolyte imbalance
  • myopathies
  • drug addiction or suspected
  • bowel disease
  • allergy to drugs
  • taking any medications

研究组 & 干预措施

group R

Placebo Comparator

Participants are administered a dose of 0.3mg of ramosetron (conventional antiemetics) intravenously followed by continuous infusion of 120mL normal saline at a rate of 10mL/min.

干预措施: Ammonium Glycyrrhizinate (Drug)

group G

Active Comparator

participants are administered a dose of 0.3mg of ramosetron followed by continuous infusion of mixture of 20mL glycyrrhizin and 100mL normal saline (total 120mL) at a rate of 10mL/min.

干预措施: Ammonium Glycyrrhizinate (Drug)

结局指标

主要结局

the incidence of postoperative nausea and vomiting (PONV)

时间窗: up to 24 hours after discharge from postanesthetic care unit (PACU)

assessing the incidence of postoperative nausea and vomiting with ordinal scale (0=none, 1=nausea, 2=retching, 3= vomiting)

次要结局

未报告次要终点

研究者

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

Yea-Ji Lee

clinical assistant professor

Konkuk University Medical Center

研究点 (1)

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