The Effect of Prevention and Treatment of Transcutaneous Electrical Acupoint Stimulation on Postoperative Dizziness in Patients With Hemifacial Spasm Undergoing Microvascular Decompression Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- The incidence of dizziness at 2 hours after returning to the ward on the day of surgery
研究概览
简要总结
To observe the prevention and treatment effect of transcutaneous electrical acupoint stimulation (TEAS) on postoperative dizziness in patients with hemifacial spasm undergoing microvascular decompression surgery, and its possible mechanisms.
详细描述
Hemifacial spasm (HFS) is mainly caused by vascular compression on the roots of the VII cranial nerves from the brain stem. Microvascular decompression (MVD) is the exact surgical method for the treatment of HFS, but the incidence of dizziness and postoperative nausea and vomiting (PONV) after MVD is extremely high. Despite the use of dual antiemetic therapy during the operation, the incidence of PONV within 24 hours after MVD is still as high as 66.7%. Medication alone has limited effects on dizziness and PONV treatment after MVD. Meta-analysis shows that transcutaneous electrical acupoint stimulation (TEAS) is associated with the reduction of post-emetic remedies and the incidence of dizziness after general anesthesia, and it can be integrated into the multi-modal therapy of PONV. Therefore, the purpose of our study is to observe the prevention and treatment effect of TEAS on postoperative dizziness in patients with hemifacial spasm undergoing microvascular decompression surgery, and explore its possible mechanisms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status: I-III
- •Body mass index (BMI): 18-30
- •Diagnosed of hemifacial spasm
- •Undergoing microvascular decompression surgery
排除标准
- •Pregnant or lactating women
- •Poorly controlled hypertension or poorly controlled diabetes, severe cardiovascular and cerebrovascular diseases and mental illness
- •Cardiac pacemakers
- •Scars on bilateral Neiguan acupoints or on the mastoid area
- •Upper limb nerve injury
- •Raynaud's syndrome
- •Motion sickness or PONV history
- •Eye diseases (glaucoma, cataracts, eye trauma, etc.) or previous eye surgery
- •Participate in other clinical trials
结局指标
主要结局
The incidence of dizziness at 2 hours after returning to the ward on the day of surgery
时间窗: 2 hours after returning to the ward on the day of surgery
The patients and their families will be asked to record a diary about their symptoms of dizziness, nausea, vomiting and headache after surgery, and they will be followed up after surgery.
次要结局
- The incidence and severity of postoperative nausea(In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward.)
- The number of vomiting after surgery(In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward.)
- Changes in intraocular pressure before and after surgery(Before anesthesia induction, and before leaving PACU on the day of surgery.)
- Gastrin and 5-Hydroxytryptamine (5-HT) levels in serum and cerebrospinal fluid(The peripheral blood samples will be collected on the day of surgery, and on postoperative day 1. The CSF samples will be collected on the day of surgery.)
- The use of remedial drugs after surgery(From the day of surgery to 72 hours after surgery.)
- The incidence and severity of postoperative headache(In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward.)
- Numerical rating scale (NRS) score of postoperative dizziness(In PACU after extubation, and 2 hours, 6 hours, 24 hours, 48 hours, 72 hours after returning to the ward.)
- Postoperative duration of stay in hospital(From the day of surgery to the day of discharge.)
- Postoperative complications monitoring(From the day of surgery to the day of discharge.)
- Dizziness symptoms 4 weeks after discharge(4 weeks after discharge.)
研究者
Yi Feng, MD
Chief of the Anesthesiology Department
Peking University People's Hospital