Clinical Evaluation of ADCT to Accelerate Perioperative Rehabilitation of Pneumonectomy

NCT04887090 | Unknown DMC

• 1 other identifier: 20210421
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

This project intends to develop a clinical randomized controlled study of ADCT (acupuncture and drug compound technology) in accelerating the recovery of patients during the perioperative period of pneumonectomy. The ADCT the investigators proposed is a characteristic technology that uses acupuncture-related technologies to replace part of the dosage of narcotic drugs. With the support of the investigators' preliminary research results of ADCT, sequential TEAS (transcutaneous electrical acupoints stimulation) treatment before, during and after the operation promoted recovery after thoracoscopic lung resection. Compared with electroacupuncture, TEAS has the advantages of non-invasive, easy to repeat, safe, and low cost, and it has widely been accepted by patients. In view of the investigators' previous clinical observations and conclusions, ADCT in the perioperative period of lung resection surgery can indeed play a good role in organ protection and reduce surgical stress reaction. Therefore, it is necessary to further clarify the advantages and application value of ADCT and provide evidence-based medical evidence. is in accelerating the perioperative period of rehabilitation, it is imminent to formulate a standardized, practical, effective and conducive to the promotion and application of acupuncture and medicine compound technology in hospitals at all levels during the perioperative period of combined Chinese and Western medicine prevention and treatment programs. In order to formulate and optimize the application of ADCT in the entire perioperative period of lung resection surgery, and promote the establishment of the first perioperative rehabilitation management and treatment model based on ADCT in accelerated lung resection surgery to facilitate clinical promotion.

Conditions

Acupuncture Therapy; Pneumonectomy; Perioperative Period; Analgesia

Keywords

Acupuncture Therapy; Pneumonectomy; Perioperative Recovery

Outcome Measures

Primary Outcomes (1)

• Postoperative chest tube removal time (h)

  The time from the end of surgery to the removal of the thoracic catheter will be recorded

  up to 2 weeks after surgery

Secondary Outcomes (9)

• First exhaust time after operation (h)

  up to 1 week after surgery

• First defecation time after operation (h)

  up to 1 week after surgery

• Visual Analog Scale of Pain

  The third day before surgery, the second TEAS treatment on the first day after surgery, and the second TEAS treatment on the second day after surgery.

• Duration of postoperative hospital stay (d)

  up to 2 weeks after surgery

• C-reactive protein (CRP,mg/L)

  The third day before surgery, the second TEAS treatment on the first day after surgery, and the second TEAS treatment on the second day after surgery.

Study Arms (2)

Acupuncture and drug compound technology group

EXPERIMENTAL

Routine perioperative management and transcutaneous electrical acupoints stimulation treatment

Device: Acupuncture and Drug Compound Technology; Other: Routine perioperative management

Control group

OTHER

Routine perioperative management

Other: Routine perioperative management

Interventions

Acupuncture and Drug Compound Technology DEVICE

Before operation: The points of the meridian: Hegu, Neiguan, Chize, Zusanli, both sides are taken. TEAS (transcutaneous electrical acupoints stimulation) was performed every day for three days before the operation, using the Han's acupoint nerve stimulator to adjust the density and density waveforms at a frequency of 2/100 Hz (Hz). Current intensity is 10mA, and all acupuncture points are continuously stimulated for 30 minutes. During the operation: take the acupoints Hegu, Neiguan, Houxi, and Zhigou on both sides and give TEAS 30 minutes before induction of anesthesia. The stimulation intensity and frequency are the same as those before the operation until the end of the operation. Postoperative: Take the acupoints Chize, Waiguan, Taichong, and Yanglingquan, and take both sides. TEAS will be performed every 12 hours from the first day after surgery. Each treatment is 30 minutes until 48 hours after surgery. The intensity and frequency are the same as before surgery.

Also known as: Transcutaneous electrical acupoints stimulation treatment

Acupuncture and drug compound technology group

Routine perioperative management OTHER

Comprehensive evaluation of cardiopulmonary function, preparation of respiratory tract, active treatment of coexisting diseases before operation, correction of water and electrolyte disorders and hypoproteinemia before operation. To prevent cross-infection during the operation, the intraoperative blood volume should be supplemented within the tolerance of cardiac function, the tissue perfusion should be sufficient, and the infusion should be uniform. Strengthen respiratory care after operation, prevent cardiovascular complications, pay attention to the speed and amount of blood transfusion, encourage early activities, promote lung expansion and prevent thrombophlebitis.

Acupuncture and drug compound technology group; Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with pulmonary nodules requiring thoracoscopic surgery.
• Understand and agree to participate in this study and sign the informed consent.

You may not qualify if:

• Patients who had previously received TEAS.
• Patients with local skin infection of acupoints.
• Patients with nerve damage in the upper or lower extremities.
• Participants who had participated in or were participating in other clinical trials within 1 month prior to enrollment.

Sponsors & Collaborators

• Shanghai Yueyang Integrated Medicine Hospital: lead

Related Publications (1)

• Zhang J, Wu X, Ju C, Kurexi S, Zhou X, Wang K, Chen T. Efficacy and safety of transcutaneous electrical acupoint stimulation for preoperative anxiety in thoracoscopic surgery: a randomized controlled trial. Front Med (Lausanne). 2025 Apr 7;12:1527993. doi: 10.3389/fmed.2025.1527993. eCollection 2025.

  PMID: 40259979 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Dean

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 14, 2021
• Study Start: July 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: December 31, 2022
• Last Updated: July 8, 2021

Record last verified: 2021-07