Amisulpride Used for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery: a Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 526
- 主要终点
- Complete remission (CR) rate within 24 hours postoperatively
研究概览
简要总结
This study aims to focus on patients undergoing gynecological laparoscopic surgery and further evaluate the role of amisulpride in preventing postoperative nausea and vomiting in these patients.
详细描述
Gynecological laparoscopic surgery patients usually combine multiple high-risk factors such as being 'female,' undergoing 'laparoscopic procedures,' and having 'gynecological surgery,' making the prevention and treatment of PONV a key focus and challenge.Among patients undergoing gynecological laparoscopic surgery, there is still a lack of targeted clinical data support.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1. 18<BMI≤30kg/m2
- •Patients scheduled to undergo gynecological laparoscopic surgery (e.g., ovary, fallopian tube, uterus, and gynecological tumors, etc., with an expected surgery duration of ≤3 hours)
排除标准
- •1. ASA class IV or above
- •Long-term use of opioid drugs or non-steroidal anti-inflammatory drugs
- •Undergoing radiotherapy and chemotherapy 4.Allergic to the medication used 5.Pregnant or breastfeeding women 6.Previously existing vestibular disorders or chronic dizziness, easily nauseous 7.Recent use of antiemetic drugs or prophylactic antiemetic regimen (within 7 days before surgery) 8.Presence of neurological or psychiatric disorders, or cognitive impairment
研究组 & 干预措施
Amisulpride
Receiving amisulpride (5mg) as postoperative prophylactic antiemetic drugs
干预措施: Tropisetron (Drug)
Tropisetron
receiving tropisetron (2mg) as postoperative prophylactic antiemetic drugs
结局指标
主要结局
Complete remission (CR) rate within 24 hours postoperatively
时间窗: 1 day
The proportion of patients who, within 24 hours after surgery, experience neither vomiting episodes (vomiting/retching) nor require rescue antiemetic medication
次要结局
未报告次要终点