Effect of Acupuncture on Postoperative Nausea and Vomiting in Lumbar Disc Herniation Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- PONV
研究概览
简要总结
In this study, the hypothesis that bilateral acupuncture needling at the Neiguan (PC6) point during the intraoperative period, in addition to the 0.15 mg/kg dose of ondansetron (5-HT3 antagonist) frequently used for postoperative nausea and vomiting (PONV) prophylaxis in patients undergoing lumbar disc herniation surgery, would reduce the incidence of PONV was investigated. PONV was defined as the presence of nausea and vomiting within 24 hours postoperatively.
详细描述
The study will include patients aged 18 years and over, with (American Society of Anesthesiologists) ASA physical status I to II, and scheduled for one or two-level lumbar disc herniation surgery under general anesthesia. Patient characteristics (age, gender, body mass index, etc.) and postoperative nausea and vomiting (PONV) risk factors such as history of PONV, motion sickness, and history of not smoking will be recorded. The primary outcome parameter will be the incidence of PONV within 24 hours postoperatively. The severity of nausea in patients who develop nausea in the postoperative period will be assessed using a Likert scale between 0 and 10. PONV will be defined as vomiting, significant nausea (numerical rating scale [NRS] ≥4), and/or need for rescue medication. Patients will be assessed for PONV at 0, 2, 4, 12, and 24 hours using a Likert scale. Emetic attacks, pain and severity of pain, nausea and severity of nausea, need for additional analgesics, and administration of antiemetic rescue medication will be assessed as secondary outcome parameters. The severity of pain and nausea in patients who develop postoperative pain will be assessed using an 11-point numerical rating scale, where '0' indicates the absence of symptoms and '10' indicates the maximum severity. PONV within the first two hours will be defined as 'early', and within 2-24 hours after awakening will be defined as 'late'. Nausea will be defined as the desire to vomit, and vomiting will be defined as the forceful expulsion of stomach contents.
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
- Single (Participant)
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 and above
- •ASA physical status I to II
- •One or two level lumbar disc herniation surgery under general anesthesia
排除标准
- •body mass index >35 kg/m²)
- •history of drug use
- •nausea and vomiting before surgery
- •psychiatric disorders
- •use of antipsychotic or antiemetic drugs
- •severe heart disease
- •central nervous system diseases
- •vertebrobasilar artery insufficiency
- •cytostatic therapy
- •vestibular diseases
- •renal and/or hepatic dysfunction
- •presence of fistula, neuropathy and paralysis in the extremity to be treated
- •patient's refusal to accept acupuncture
- •pregnant patients
- •presence of bleeding diathesis
- •patients in a condition where cooperation cannot be established in the post-operative period (mental retardation etc.)
研究组 & 干预措施
Acupuncture
patients will be given acupuncture in addition to standard medical treatment to prevent ponv
干预措施: acupuncture (Other)
No Acupuncture
patients will be given acupuncture in addition to standard medical treatment to prevent ponv
干预措施: No acupuncture (Other)
结局指标
主要结局
PONV
时间窗: 24 hours
The primary outcome of the study was the incidence of postoperative nausea and/or vomiting
次要结局
- Severity of nausea(24 hours)
- 11 - point numerical rating scale (NRS)(24 hours)
- Rescue emetic requirement(24 hours)
研究者
Gökhan Erdem
Anesthesiology and Reanimation specialist doctor
Ankara City Hospital Bilkent