Ultrasound-guided Cervical Vagus Nerve Block Prevents Ocularvagal Reflex in Ophthalmic Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes of heart rate
研究概览
简要总结
In ophthalmic surgery, surgical operations such as pulling certain eye tissues or compressing the eyeball often leads to bradycardia, arrhythmia even cardiac arrest, bradypnea, nausea and vomiting and elevated blood sugar level. The condition is called the ocularvagal reflex (OVR). Traditionally, when the bradycardia or arrhythmia happens, the operation has to be suspended, and atropine or isoproterenol is given intravenously to treat the bradycardia. Vagus nerve block may be an effective way to prevent and alleviate this vagal reflex. However it is difficult to perform the nerve block with anatomical landmark (blind) methods. In this study, the investigators used ultrasound-guided right cervical vagus nerve block to reduce the incidence of the OVR. The researchers hypothesized that low concentrations of lidocaine or ropivacaine can block the right cervical vagus nerve and reduce the incidence of intraoperative OVR. Researchers evaluated the changes of heart rate, blood pressure, oxygen saturation, and airway pressure in patients undergoing high-risk OVR surgery.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients received surgeries with high-risk OVR, including the strabismus surgery, the posterior scleral reinforcement, and the insertion of ocular implant.
排除标准
- •Those who have pre-existed vocal cord damage before surgery (such as hoarseness, electronic laryngoscopy shows fixed vocal cords or arytenoid cartilage dislocation).
- •Those with a history of surgery on the both sides of the neck (eg, thyroidectomy, carotid endarterectomy).
- •American Society of Anesthesiologist (ASA) Grade > 3
- •Patients with infection at the neck puncture site, or severe coagulation abnormalities before surgery, or a history of local anesthetic allergy, or who have a pacemaker.
研究组 & 干预措施
Control group
Conventional monitor and treatment The surgery is performed after patient is under general anesthesia. If patient's heart rate significantly slows down or bradycardia/arrhythmia happens, the surgeon will be asked to suspend the operation. Meanwhile, atropine (0.01-0.02mg/kg) is given intravenously to increase the heart rate. If atropine fails to increase the heart rate, isoproterenol (1-2 μg/per time) will be given intravenously to increase the heart rate.
干预措施: Bradycardia Treatment (Drug)
Nerve block group
After the patient is under general anesthesia, an attending physicians perform the ultrasound-guided cervical vagus nerve block (using a 50mm Braun nerve stimulation needle, and the patients were injected with 10ml of lidocaine or ropivacaine ). Then the operation starts. If patient's heart rate significantly slows down or bradycardia/arrhythmia happens, the surgeon will be asked to suspend the operation. Meanwhile, atropine (0.01-0.02mg/kg) is given intravenously to increase the heart rate. If atropine fails to increase the heart rate, isoproterenol (1-2 μg/per time) will be given intravenously to increase the heart rate. After endotracheal tube is removed, the patient will be followed up for next 24 hours.
干预措施: Ultrasound guided vagus nerve block (Procedure)
Nerve block group
After the patient is under general anesthesia, an attending physicians perform the ultrasound-guided cervical vagus nerve block (using a 50mm Braun nerve stimulation needle, and the patients were injected with 10ml of lidocaine or ropivacaine ). Then the operation starts. If patient's heart rate significantly slows down or bradycardia/arrhythmia happens, the surgeon will be asked to suspend the operation. Meanwhile, atropine (0.01-0.02mg/kg) is given intravenously to increase the heart rate. If atropine fails to increase the heart rate, isoproterenol (1-2 μg/per time) will be given intravenously to increase the heart rate. After endotracheal tube is removed, the patient will be followed up for next 24 hours.
干预措施: Bradycardia Treatment (Drug)
结局指标
主要结局
Changes of heart rate
时间窗: during the operation
Changes of heart rate in beat per minute from Baseline
次要结局
- Changes of Peak airway pressure(during the operation)
- Changes of Blood pressure(during the operation)
- Changes of SpO2(during the operation)
- Nausea and vomiting in times(24 hours after the operation)
- Voice changes in grades (0-3)(24 hours after the operation)
研究者
Qingxiang Mao
professor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University