Transcutaneous Electrical Acupoint Stimulation Alleviate Postoperative Depression in Video-assisted Thoracoscopic Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Beck Depression Inventory score 30 days postoperatively
研究概览
简要总结
Depression can significantly affect postoperative rehabilitation quality and increase the mortality of patients who receive video-assisted thoracoscopic surgery (VATS). This study intend to evaluate the transcutaneous electrical acupoint stimulation (TEAS) of VATS safety and the efficacy of the postoperative depression compared to a sham group.
详细描述
Depression is a common psychiatric problem in perioperative period in patients who receive video-assisted thoracoscopic surgery (VATS). Multiple research have pointed out that the incidence of postoperative depression can be as high as 11.8%-34% . Brian et al.reported that the iIncidence of new depressive episodes one year after VATS was as high as 12.4%. Depression not only reduces treatment compliance and quality of life, prolongs hospital stays, and increases postoperati''ve mortality, but can also exacerbate pain and reduce sleep quality, significantly affecting postoperative recovery .
Modern studies report that surgical trauma, pain, sleep disorders, and stress responses increases inflammatory factors such as TNF-α and IL-6, and cause inflammation. This results in a decrease in the production of the monoamine neurotransmitters serotonin and norepinephrine in the brain, which causes depression. Therefore, the antidepressant drugs widely used in clinical practice are serotonin reuptake inhibitors; however, they are not only expensive and slow to act, but also have various side reactions, such as decreased libido, sexual dysfunction, headache, gastrointestinal symptoms, irritability, and anxiety. Further, long-term use may also cause damage to the nervous system.
Transcutaneous acupoint electrical stimulation (TAES) is an innovative diagnostic and therapeutic technique used in traditional Chinese medicine that integrates transcutaneous nerve electrical stimulation with meridian acupoints. It offers numerous advantages, such as being noninvasive, painless, simple to operate, with high treatment compliance, and minimal side effects. Multiple studies have shown that TAES not only has analgesic, anti-stress, and anti-inflammatory effects and can improve postoperative sleep disorders but can also directly increase the concentration of serotonin in the brain. Therefore, TAES may effectively improve post-VATS depression symptoms. This prospective, randomized, controlled, double blind, single-arm, single-center study will provide insights oninto the safety and effectiveness of TAES in improving post-VATS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The traditional Chinese medicine doctor will administer the intervention based on the randomized grouping to ensure the double-blind nature of the study. Neither anesthesiologists nor outcome assessors will aware of patient randomization. The participants will be blinded with reference to Song et al.'s study. In TAES group, electrode pads will be fixed on the bilateral HT7 (Shenmen), PC6 (Neiguan), LI4 (Hegu), LU5 (Chize) and Extra (Anmian), the current set based on the participants ' maximum tolerance and muscle fibrillation. In the Sham-TAES group, electrodes will be fixed at 4 cm interior to the bilateral Shenmen, Neiguan, Hegu, Chize, and Anmian acupoints , and the frequency current setting given in the same way as in the TAES group to make the patients think that they received the TAES treatment. Therefore, all participants will be unaware of randomization
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
- •Unilateral VATS performed under general anesthesia due to pulmonary nodules; The age ranged from 18 to 65 years; American Society of Anesthesiologists (ASA) classification II-III; The patient has normal consciousness, with no facial paralysis, is capable of cooperating with treatment, and provides signed informed consent.
排除标准
- •Merge the skin of local acupoint infectors; Patients with upper extremity nerve injury; Patients with implanted pacemakers; Alcoholism or long-term use of opioid, hormonal, and anti-inflammatory analgesics; Allergic to the drug used in the study; Those who recently received TAES or acupoint treatment; Patients with history of psychiatric disorders or current use of psychiatric medication; Receiving treatment with monoamine oxidase inhibitors; Severe disease of the heart, brain, liver, kidneys, or hematopoietic system; Patients unable to cooperate with the study for any reason
结局指标
主要结局
Beck Depression Inventory score 30 days postoperatively
时间窗: 30 days postoperatively
The self-rating Scale for Depression consists of 21 groups of questions, each group has 4 statements, and each sentence corresponds to an Arabic numeral.Participants choose the statement that best suits their situation according to their own feeling.After all 21 groups have been completed, the total score of each group is added
次要结局
- Beck Depression Inventory score 2 days postoperatively(2 days postoperatively)
- Serum Interleukin-6 concentration 2 days after surgery(2 days after surgery)
- Serum tumor necrosis factor-α concentration 2 days after surgery(2 days after surgery)
- 24h postoperative resting pain numerical rating scale (NRS) score(24 hours after surgery)
- 48h postoperative resting pain numerical rating scale (NRS) score(48 hours after surgery)
- 24h postoperative moving NRS pain score(24 hours after surgery)
- 48h postoperative moving NRS pain score(48 hours after surgery)
- Dosage of patient controlled intravenous analgesia 24h after surgery(24 hours after surgery)
- Dosage of patient controlled intravenous analgesia 48h after surgery(48 hours after surgery)
- Sleep NRS score 2 days after surgery(2 days after sergury)
- TAES-related complications(2 days after sergury)