TAES Alleviate Post-VATS Depression

Official title

Transcutaneous Electrical Acupoint Stimulation Alleviate Postoperative Depression in Video-assisted Thoracoscopic Surgery: a Randomized Controlled Trial

Overview

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.

Detailed description

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.

Interventions

• Behavioral Transcutaneous electrical acupoint stimulation
  After entering the operating room, an experienced traditional Chinese medicine doctor will locate the bilateral Shenmen, Neiguan, Hegu, Chize, and Anmian acupoints, and sham acupoints. The target treatment acupoints will be wiped with 75% ethanol, and after the ethanol had evaporated, electrode pads (50 × 50 mm) will be placed and fixed according to the different groups. Thirty minutes before anesthesia, a TAES stimulator (Hwato Electronic Acupuncture Treatment Instrument, model no: SDZ-III; Suz
• Behavioral Sham-TAES
  After entering the operating room, an experienced traditional Chinese medicine doctor will locate the bilateral sham acupoints. The Sham acupoints is 4 cm interior to the bilateral Shenmen, Neiguan, Hegu, Chize, and Anmian acupoints. The sham acupoints will be wiped with 75% ethanol, and after the ethanol had evaporated, electrode pads (50 × 50 mm) will be placed and fixed according to the different groups. Thirty minutes before anesthesia, a TAES stimulator (Hwato Electronic Acupuncture Treatme

Primary outcome measures

• Beck Depression Inventory score 30 days postoperatively [Time frame: 30 days postoperatively]

Secondary outcome measures (11)

• Beck Depression Inventory score 2 days postoperatively [Time frame: 2 days postoperatively]
• Serum Interleukin-6 concentration 2 days after surgery [Time frame: 2 days after surgery]
• Serum tumor necrosis factor-α concentration 2 days after surgery [Time frame: 2 days after surgery]
• 24h postoperative resting pain numerical rating scale (NRS) score [Time frame: 24 hours after surgery]
• 48h postoperative resting pain numerical rating scale (NRS) score [Time frame: 48 hours after surgery]
• 24h postoperative moving NRS pain score [Time frame: 24 hours after surgery]
• 48h postoperative moving NRS pain score [Time frame: 48 hours after surgery]
• Dosage of patient controlled intravenous analgesia 24h after surgery [Time frame: 24 hours after surgery]
• Dosage of patient controlled intravenous analgesia 48h after surgery [Time frame: 48 hours after surgery]
• Sleep NRS score 2 days after surgery [Time frame: 2 days after sergury]
• TAES-related complications [Time frame: 2 days after sergury]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

China · 1 center

• Fuling Central Hospital of Chongqing — Fuling

Publications

• He Y, Yuan M, He C, Zhu D, Wang F. The Effects of Transcutaneous Acupoint Electrical Stimulation on Cancer-related Fatigue and Negative Emotions in Cancer Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Contrast Media Mol Imaging. 2022 Jul 31;2022:1225253. doi: 10.1155/2022/1225253. eCollection 2022. PMID 35965622
• Tsay SL, Cho YC, Chen ML. Acupressure and Transcutaneous Electrical Acupoint Stimulation in improving fatigue, sleep quality and depression in hemodialysis patients. Am J Chin Med. 2004;32(3):407-16. doi: 10.1142/S0192415X04002065. PMID 15344424
• Wang H, Yang BZ, Guo Q, Jing ZY. [Effect of transcutaneous electrical acupoint stimulation combined with epidural labor analgesia on postpartum depression]. Zhen Ci Yan Jiu. 2021 Mar 25;46(3):231-4. doi: 10.13702/j.1000-0607.200249. Chinese. PMID 33798297
• Chen WY, Li L, Wang HY, Jiang N. [Effects of Transcutaneous Electrical Acupoint Stimulation for Depression in Late Pregnancy and Impacts on Inflammatory Cytokines]. Zhen Ci Yan Jiu. 2018 Jan 25;43(1):44-8. doi: 10.13702/j.1000-0607.160781. Chinese. PMID 29383894
• Agrawal S, Szmit M, Welna M, Rudnicki J, Agrawal A, Gozdzik W. Transcutaneous electrical acupoint stimulation to reduce opioid consumption in patients undergoing inguinal hernia repair: protocol for a randomized controlled trial. Trials. 2022 Dec 29;23(1):1064. doi: 10.1186/s13063-022-07019-9. PMID 36581999
• Chen J, Zhang Y, Li X, Wan Y, Ji X, Wang W, Kang X, Yan W, Fan Z. Efficacy of transcutaneous electrical acupoint stimulation combined with general anesthesia for sedation and postoperative analgesia in minimally invasive lung cancer surgery: A randomized, double-blind, placebo-controlled trial. Thorac Cancer. 2020 Apr;11(4):928-934. doi: 10.1111/1759-7714.13343. Epub 2020 Feb 16. PMID 32062864
• Song B, Chang Y, Li Y, Zhu J. Effects of Transcutaneous Electrical Acupoint Stimulation on the Postoperative Sleep Quality and Pain of Patients After Video-Assisted Thoracoscopic Surgery: A Prospective, Randomized Controlled Trial. Nat Sci Sleep. 2020 Oct 27;12:809-819. doi: 10.2147/NSS.S270739. eCollection 2020. PMID 33154688
• Ulett GA, Han S, Han JS. Electroacupuncture: mechanisms and clinical application. Biol Psychiatry. 1998 Jul 15;44(2):129-38. doi: 10.1016/s0006-3223(97)00394-6. PMID 9646895

Identifiers

NCT: NCT06718231 · TAES for VATS depression

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗