Electroacupuncture Combined With 5-HT3 Receptor Inhibitor for the Prevention of Postoperative Nausea and Vomiting in High-risk Patients Undergoing Thoracoscopic Surgery for Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Incidence of postoperative nausea and vomiting (PONV) within 24 hours after surgery
研究概览
简要总结
This prospective, randomized controlled study aims to evaluate the efficacy and safety of electroacupuncture combined with 5-HT3 receptor inhibitor for preventing postoperative nausea and vomiting (PONV) in high-risk patients undergoing thoracoscopic lung cancer surgery. The primary outcome is the incidence of PONV within 24 hours after surgery.
详细描述
Postoperative nausea and vomiting (PONV) is a common complication after thoracic surgery, especially in high-risk patients, which seriously affects postoperative recovery and quality of life. 5-HT3 receptor inhibitors are commonly used for PONV prophylaxis, but their efficacy is limited in some high-risk populations. Electroacupuncture has been shown to reduce PONV in clinical settings.
This study aims to investigate the safety and efficacy of electroacupuncture (EA) combined with 5-HT3 receptor inhibitor dolasetron in preventing nausea and vomiting in high-risk patients after video-assisted thoracoscopic (VATS) surgery. This is a prospective, randomized, sham-controlled, blinded study designed to enroll perioperative patients at high risk of postoperative nausea and vomiting (PONV) (with an Apfel score ≥ 3) who are scheduled to undergo video-assisted thoracoscopic surgery (VATS) for lung resection. Eligible patients will be randomly assigned to 2 sessions of EA or sham electroacupuncture (SA) during the perioperative time. All patients will receive prophylactic antiemetic medication of dolasetron and dexamethasone. The primary outcome will be the incidence of PONV within 24 hours after surgery. The secondary outcomes include the incidence of postoperative nausea (PON), postoperative vomiting (POV), or PONV at different time intervals within 48 hours after surgery (upon awakening, 6, 24, 48 hours postoperatively), severity of PON (assessed by Visual Analogue Scale, VAS score), frequency of POV, usage rate of rescue antiemetic drugs, average dosage intensity of opioids administered during and after surgery, average exhaust time and average defecation time; average length of hospital stay, and recording of adverse events related to acupuncture.
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
The clinical trial coordinators and acupuncturists are aware of the treatment assignments; while the subjects, anesthesiologists, perioperative management physicians, baseline and efficacy assessors, and statistical analysts are all blinded.
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
- •Age ≥ 18 years;
- •American Society of Anesthesiologists (ASA) physical status I-III;
- •Body mass index (BMI) 18-30 kg/m²;
- •Scheduled for elective video-assisted thoracoscopic surgery (VATS) lobectomy, segmentectomy, or wedge resection;
- •Expected to receive postoperative opioid analgesia, with an Apfel risk score ≥ 3;
- •Normal pulmonary function, without severe cardiovascular, hepatic, or renal abnormalities;
- •No infection around the acupuncture sites;
- •Voluntary written informed consent provided by the subject.
排除标准
- •Severe systemic diseases, such as cardiovascular, hepatic, or renal abnormalities, or poor pulmonary function;
- •Subjects with cognitive dysfunction or psychological disorders;
- •History of previous esophageal or gastric surgery;
- •Hypersensitivity to acupuncture or any study medications;
- •Severe infection or history of surgery around the acupuncture sites;
- •Pregnant or lactating women;
- •Long-term opioid use;
- •Conversion to open surgery;
- •Acupuncture treatment received within 1 month prior to enrollment.
研究组 & 干预措施
Electroacupuncture (EA) group
On the basis of receiving dolasetron and dexamethasone for preventing postoperative nausea and vomiting (PONV) during the perioperative period of video-assisted thoracoscopic surgery (VATS) for lung resection, the participants will receive electroacupuncture at 30 minutes before anesthesia induction and 4 hours after surgery.
干预措施: Prophylactic administration of dolasetron (Drug)
Electroacupuncture (EA) group
On the basis of receiving dolasetron and dexamethasone for preventing postoperative nausea and vomiting (PONV) during the perioperative period of video-assisted thoracoscopic surgery (VATS) for lung resection, the participants will receive electroacupuncture at 30 minutes before anesthesia induction and 4 hours after surgery.
干预措施: Electroacupuncture (Other)
sham electroacupuncture (SA) group
On the basis of receiving dolasetron and dexamethasone for preventing postoperative nausea and vomiting (PONV) during the perioperative period of video-assisted thoracoscopic surgery (VATS) for lung resection, the participants will receive sham electroacupuncture at 30 minutes before anesthesia induction and 4 hours after surgery.
干预措施: Prophylactic administration of dolasetron (Drug)
sham electroacupuncture (SA) group
On the basis of receiving dolasetron and dexamethasone for preventing postoperative nausea and vomiting (PONV) during the perioperative period of video-assisted thoracoscopic surgery (VATS) for lung resection, the participants will receive sham electroacupuncture at 30 minutes before anesthesia induction and 4 hours after surgery.
干预措施: Sham electroacupuncture (Other)
结局指标
主要结局
Incidence of postoperative nausea and vomiting (PONV) within 24 hours after surgery
时间窗: within 24 hours postoperatively
次要结局
- Incidence of PON, POV, and PONV(within 48 hours postoperatively)
- Severity of PONV assessed by PONV VAS score(within 48 hours postoperatively)
- Usage rate of rescue antiemetic medication(within 48 hours postoperatively)
- Sufentanil consumption during postoperative PCIA(within 48 hours postoperatively)
- Mean time to first postoperative flatus(From surgery to first postoperative flatus, up to 7 days postoperatively)
- Mean length of postoperative hospital stay(From surgery to hospital discharge, up to 30 days postoperatively)
研究者
Cai Xiaoyue
Associate Chief Physician
Shanghai Chest Hospital