TAES Alleviate Post-VATS Depression

NCT06718231 | Not Yet Recruiting

• 1 other identifier: TAES for VATS depression
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression After Video-assisted Thoracoscopic Surgery

Keywords

Transcutaneous electrical acupoint stimulation (TAES); depression; video-assisted thoracoscopic surgery; interleukin-6; tumor necrosis factor-α

Outcome Measures

Primary Outcomes (1)

• Beck Depression Inventory score 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

  30 days postoperatively

Secondary Outcomes (11)

• 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

Study Arms (2)

Group T

ACTIVE COMPARATOR

the electrodes will be fixed at acupointsShenmen,Neiguan,Hegu,Chize,Anmian bilaterally

Behavioral: Transcutaneous electrical acupoint stimulation

Group S

SHAM COMPARATOR

the electrode pads will be fixed at the bilateral sham acupoints

Behavioral: Sham-TAES

Interventions

Transcutaneous electrical acupoint stimulation BEHAVIORAL

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; Suzhou Medical Appliances Co. Ltd, Suzhou, China) will be connected with a frequency setting of 2/10 Hz (2 Hz for 10 s and 10 Hz for 5 s), in dense-disperse mode. The current intensity will be set according to the patient's maximum tolerance and muscle twitching and continued until the end of the surgery.

Group T

Sham-TAES BEHAVIORAL

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 Treatment Instrument, model no: SDZ-III; Suzhou Medical Appliances Co. Ltd, Suzhou, China) will be connected with a frequency setting of 2/10 Hz (2 Hz for 10 s and 10 Hz for 5 s), in dense-disperse mode. The current intensity will be set according to the patient's maximum tolerance and muscle twitching and continued until the end of the surgery

Group S

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fuling Central Hospital of Chongqing City: lead

Study Sites (1)

Fuling Central Hospital of Chongqing

Fuling, Chongqing Municipality, 408000, China

Location

Related Publications (23)

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  PMID: 35965622 RESULT

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• 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.

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• Cheng X, Wang H, Diao M, Jiao H. Effect of S-ketamine on Postoperative Quality of Recovery in Patients Undergoing Video-Assisted Thoracic Surgery. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt B):3049-3056. doi: 10.1053/j.jvca.2022.04.028. Epub 2022 Apr 26.

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  RESULT

• Gan SL, Long YQ, Wang QY, Feng CD, Lai CX, Liu CT, Ding YY, Liu H, Peng K, Ji FH. Effect of esketamine on postoperative depressive symptoms in patients undergoing thoracoscopic lung cancer surgery: A randomized controlled trial. Front Psychiatry. 2023 Mar 15;14:1128406. doi: 10.3389/fpsyt.2023.1128406. eCollection 2023.

  PMID: 37009103 RESULT

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Jun hua Zhang, M.D.

CONTACT

+8615213680591; okzjh000@163.com

Xiang Zou, M.D.

CONTACT

+8613996812330

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: December 20, 2024
• Primary Completion: January 20, 2026
• Study Completion: March 10, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)