Comparison of Anesthesia Effects of Sevoflurane and Propofol Combined With Dexmedetomidine in Intraoperative Neuromonitoring During Thyroidectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The times of movements or the times of spontaneous vocal cords activities
研究概览
简要总结
According to the previous studies, it is reported that the use of sevoflurane in the maintenance of anesthesia may lead to delayed occurrence of positive electromyographic (EMG) signal and lower obtained signal amplitude. In this study, the investigators aimed to investigate the anesthetic effect of sevoflurane combined with dexmedetomidine for neuromonitoring during thyroid surgery. The investigators hypothesize that sevoflurane combined with dexmedetomidine can reduce the movement or spontaneous activity of vocal cords in patients and without affecting the EMG signals.
详细描述
Recurrent laryngeal nerve (RLN) injury is one of the most serious common complications in thyroid operation. Compared with the traditional operation under direct eye vision alone, application of intraoperative neural monitoring (IONM) is able to help surgeon in identifying the RLN during thyroid dissection, and enabling continuous monitoring of the neurological function during operation, thus reducing the incidence of intraoperative RLN injury. Sevoflurane is a common inhaled anesthetic in clinical practice, with the effect of prolonging the action time of muscle relaxants. According to the previous studies, it is reported that the use of sevoflurane in the maintenance of anesthesia may lead to delayed occurrence of positive electromyographic (EMG) signal and lower obtained signal amplitude, which may affect the surgeon's judgment on neurological function during the operation. In this study, the investigators aimed to investigate the anesthetic effect of sevoflurane combined with dexmedetomidine for neuromonitoring during thyroid surgery. The investigators hypothesize that sevoflurane combined with dexmedetomidine can reduce movement or spontaneous activity of vocal cords in patients without affecting the IONM signal.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for thyroidectomy under general anesthesia
- •American Society of Anesthesiologists (ASA) grade of I or II
- •aged 18 to 65 years
- •body mass index (BMI) < 32 kg/m2.
排除标准
- •patients with RLN or vagus nerve injury were identified preoperatively
- •severe cardiovascular, pulmonary, liver and kidney diseases
- •history of allergy to narcotic include rocuronium -pregnancy or lactation-
- •history or current usage of medication which may interfere neuromuscular transmission;
- •family or personal history of malignant hyperthermia
- •myasthenia gravis
- •potential risk of airway difficulty
- •unable to cooperate.
研究组 & 干预措施
Group DS
Anesthesia was maintained with sevoflurane and target-controlled infusion of remifentanil in the group DS
干预措施: Anesthesia was maintained with sevoflurane (Drug)
Group DP
Anesthesia was maintained with propofol and target-controlled infusion of remifentanil in the group DP
干预措施: Anesthesia was maintained with propofol (Drug)
结局指标
主要结局
The times of movements or the times of spontaneous vocal cords activities
时间窗: During the surgery
If one of the following occurred, it would be seen as 1 "movement" and add 1 in the counting: (1) visually observed body movement, including bucking. (2) spontaneous vocal cords activity. (Spontaneous vocal cords activity due to insufficient neuromuscular blocking agents, a coarsening of the monitor baseline can be seen, with a series of small waveforms typically varying from 30 to 70 μV) .
次要结局
未报告次要终点
研究者
OliviaLiu
graduate student
Affiliated Cancer Hospital & Institute of Guangzhou Medical University