Association Between Preoperative Metformin Exposure and Postoperative Nausea and Vomiting in Patients Undergoing General Anesthesia: a Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 909
- 试验地点
- 1
- 主要终点
- The incidence of PONV during 0-120 postoperative hours
研究概览
简要总结
The aim of this observational study is to investigate the potential effects of metformin on postoperative nausea and vomiting (PONV) in patients undergoing surgery under general anesthesia. The primary research question is:
Does preoperative metformin exposure influence the incidence or severity of PONV in patients undergoing general anesthesia? Patients who are already prescribed metformin as part of their routine medical management will be compared with those not taking metformin. Data on PONV occurrence, severity, and recovery outcomes will be collected through structured postoperative surveys administered after surgery.
详细描述
This is a prospective observational cohort study involving patients undergoing surgery under general anesthesia with endotracheal intubation at the Sixth Affiliated Hospital of Sun Yat-sen University. A total of 909 participants will be enrolled into either the metformin-exposed group (n=303) or the non-exposed group (n=606) . The primary outcome is the incidence of postoperative nausea and vomiting (PONV) within 0-120 hours after surgery. Secondary outcomes comprise the incidence and severity of PONV during different intervals, use of antiemetics, and quality of recovery (assessed by the QoR-15 score).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign the informed consent form;
- •Age ≥ 18 years;
- •Patients who require surgical treatment under endotracheal intubation with general anesthesia as determined by the treating physician.
排除标准
- •Emergency surgery;
- •Currently taking medications with established antiemetic effects (e.g., corticosteroids, antipsychotics) due to underlying medical conditions;
- •Cognitive impairment or psychiatric disorders that preclude cooperation with questionnaire assessments;
- •Anticipated inability to extubate the tracheal tube postoperatively, which would interfere with outcome assessment;
- •Presence of nausea and/or vomiting prior to surgery.
研究组 & 干预措施
Exposure group
Patients are already prescribed metformin before surgery
The non-exposure group
Patients are not prescribed metformin before surgery
结局指标
主要结局
The incidence of PONV during 0-120 postoperative hours
时间窗: During 0-120 hour after surgery
PONV is defined as the occurrence of any of the following symptoms: nausea, retching, or vomiting
次要结局
- The incidence PONV during 0-24 hour after surgery(During 0-24 hour after surgery)
- Use of antiemetics during 0-24 hours after surgery(During 0-24 hours after surgery)
- Use of antiemetics during 24-120 hours after surgery(During 24-120 hours after surgery)
- Use of antiemetics during 0-120 hours after surgery(During 0-120 hours after surgery)
- The incidence PONV during 24-120 hour after surgery(During 24-120 hour after surgery)
- The total severity of PONV during 0-120 hour after surgery(During 0-120 hour after surgery)
- The severity of PONV during 0-24 hour after surgery(During 0-24 hour after surgery)
- The severity of PONV during 24-120 hour after surgery(During 24-120 hour after surgery)
- Quality of Recovery (QoR-15 score) from 0 to 120 hour after surgery(Evaluated before surgery, at 24-hour, 48-hour, 72-hour, 96-hour, 120-hour after surgery)
研究者
Yang Zhao
Dr
Sixth Affiliated Hospital, Sun Yat-sen University