Clinical trial NCT04887090: Clinical Evaluation of ADCT to Accelerate Perioperative Rehabilitation of Pneumonectomy
Official title: Study on Standardization and Clinical Evaluation of Acupuncture and Drug Compound Technology to Accelerate Perioperative Rehabilitation of Pneumonectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acupuncture Therapy
Pneumonectomy
Perioperative Period
Analgesia
Keywords: Acupuncture Therapy
Pneumonectomy
Perioperative Recovery
Lead sponsor: Shanghai Yueyang Integrated Medicine Hospital
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Since the first successful pulmonary resection under acupuncture anesthesia in 1960，the clinical application and research of lung surgery under acupuncture anesthesia has gone through 60 years，serving countless patients and achieving rich results． Looking back on its development，the application of acupuncture anesthesia in lung surgery has evolved from simple acupuncture anesthesia without intubation in the 1960s to combined anesthesia of acupuncture and narcotic drugs under tracheal intubation in the early 1980s．In recent years，with the popularization of endoscopic technology，the investigators had extensively carried out thoracoscopic lung surgery under combined anesthesia of acupuncture and narcotic drugs without intubation．Clinical practice and research have indicated that the thoracoscopic lung surgery under combined anesthesia without intubation shows obvious advantages，and the selection of intraoperative anesthesia methods，acupoints and stimulation methods are becoming mature．At present，the investigators are working on expanded application of acupuncture in perioperative period of lung surgery，which shows a promising future．In the future，it is necessary to improve the theory of acupuncture anesthesia，unify the clinical operation standards，establish an objective evaluation system，and explore the mechanism of acupuncture anesthesia． 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Postoperative chest tube removal time (h)
timeFrame: up to 2 weeks after surgery
Secondary outcomes:
measure: First exhaust time after operation (h)
timeFrame: up to 1 week after surgery
measure: First defecation time after operation (h)
timeFrame: up to 1 week after surgery
measure: Visual Analog Scale of Pain
timeFrame: 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.
measure: Duration of postoperative hospital stay (d)
timeFrame: up to 2 weeks after surgery
measure: C-reactive protein (CRP,mg/L)
timeFrame: 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.
measure: Noradrenaline (NE,µg/L)
timeFrame: 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.
measure: Postoperative stay time in the intensive care unit (h)
timeFrame: up to 1 week after surgery
measure: Postoperative antibiotics use days (d)
timeFrame: up to 1 week after surgery
measure: Inpatient medical expenses
timeFrame: up to 2 weeks after surgery
Other outcomes:
Locations:
Study officials:
References: