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临床试验/NCT03705026
NCT03705026已完成不适用

Relationship Between Genetic Polymorphism and Postoperative Nausea and Vomiting Undergoing Breast Surgery With General Anesthesia in Chinese Han Population

Fujian Medical University Union Hospital0 个研究点目标入组 568 人开始时间: 2013年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
568
主要终点
Whether the participants occur nausea or not

研究概览

简要总结

Postoperative nausea and vomiting ( PONV ) is one of the common complications after general anesthesia while genetic factors may play an important role in Postoperative nausea and vomiting. In this study, the investigators investigated the relationship between gene polymorphism ( such as single nucleotide polymorphism ) of the gene HTR3A ( 5-hydroxytryptamine receptor 3A ), HTR3B ( 5-hydroxytryptamine receptor 3B ), HTR3C ( 5-hydroxytryptamine receptor 3C ) and TACR1 ( tachykinin receptor 1 ) etc. with nausea and vomiting after general anesthesia. Simultaneously, the investigators explored the influencing factors of nausea and vomiting.

详细描述

Materials and methods:

Demographic data and risk factors responsible for PONV, including the history of PONV and motion sickness, were collected preoperatively by interviewing participants the day before anesthesia.

All study subjects received a standardized anesthesia regimen. General anesthesia was induced by midazolam 0.04 mg/kg, propofol 1.5 mg/kg, sufentanil 0.4 μg/kg, and cisatracurium 0.2 mg/kg (to facilitate tracheal intubation) given intravenously.Participants' lungs were ventilated with 50% oxygen in air.

During general anesthesia, concentration of sevoflurane maintained 1.0% to 3.0% at the discretion of anesthetist who was not involved in the study. General anesthesia also uses propofol 1 mg kg-1 h-1 and sufentanil 0.1 μg kg-1 h-1 by continuous intravenous infusion. An Entropy index monitor was used to maintain the appropriate anesthesia depth by 40-60. Participants received a repeated bolus of sufentanil 0.1 μg/kg or cisatracurium intravenously on demand.

After surgery the investigators recorded the data such as Anesthesia duration, doses of sufentanil and propofol and so on.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Undergoing breast surgery with general anesthesia
  • American Society of Anesthesiologists Physical Status Classifications 1-2
  • No history of smoking
  • body mass index (BMI) <35 kg/m2

排除标准

  • Declined to participate
  • Had used antiemetics, steroids, H2 antagonists, anticholinergics, antihistamines, butyrophenones, phenothiazines, metoclopramide or opioids within 24 hours
  • Gastroesophageal reflux, gastrointestinal obstruction or ulcer, vestibular or hearing dysfunction
  • Liver impairment, renal impairment, psychiatric disorder, chronic pain
  • Pregnant and lactating patients
  • Requiring postoperative patient-controlled analgesia
  • Requiring prophylactic use of antiemetics
  • Allergic to drugs related in the study
  • Receiving chemotherapy within one week before surgery

结局指标

主要结局

Whether the participants occur nausea or not

时间窗: Period of 6 to 24 hours after surgery

Nausea was defined as a feeling of wanting to throw up or about to throw up.

Whether the participants occur vomiting or not

时间窗: Period of 6 to 24 hours after surgery

Vomiting was defined as the discharge of the stomach contents, while retching as an involuntary attempt to vomit that did not produce stomach contents. Retching was considered as vomiting.

次要结局

  • Level of nausea(Within 24 hours after surgery)
  • Number of vomiting(Within 24 hours after surgery)

研究者

申办方类型
Other
责任方
Sponsor

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