Clinical trial NCT06718231: TAES Alleviate Post-VATS Depression
Official title: Transcutaneous Electrical Acupoint Stimulation Alleviate Postoperative Depression in Video-assisted Thoracoscopic Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression After Video-assisted Thoracoscopic Surgery
Keywords: Transcutaneous electrical acupoint stimulation (TAES)
depression
video-assisted thoracoscopic surgery
interleukin-6
tumor necrosis factor-α
Lead sponsor: Fuling Central Hospital of Chongqing City
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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

Primary outcomes:
measure: Beck Depression Inventory score 30 days postoperatively
timeFrame: 30 days postoperatively
Secondary outcomes:
measure: Beck Depression Inventory score 2 days postoperatively
timeFrame: 2 days postoperatively
measure: Serum Interleukin-6 concentration 2 days after surgery
timeFrame: 2 days after surgery
measure: Serum tumor necrosis factor-α concentration 2 days after surgery
timeFrame: 2 days after surgery
measure: 24h postoperative resting pain numerical rating scale (NRS) score
timeFrame: 24 hours after surgery
measure: 48h postoperative resting pain numerical rating scale (NRS) score
timeFrame: 48 hours after surgery
measure: 24h postoperative moving NRS pain score
timeFrame: 24 hours after surgery
measure: 48h postoperative moving NRS pain score
timeFrame: 48 hours after surgery
measure: Dosage of patient controlled intravenous analgesia 24h after surgery
timeFrame: 24 hours after surgery
measure: Dosage of patient controlled intravenous analgesia 48h after surgery
timeFrame: 48 hours after surgery
measure: Sleep NRS score 2 days after surgery
timeFrame: 2 days after sergury
measure: TAES-related complications
timeFrame: 2 days after sergury
Other outcomes:
Locations:
city: Fuling
country: China
facility: Fuling Central Hospital of Chongqing
state: Chongqing
Study officials:
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