Clinical Evaluation of ADCT to Accelerate Perioperative Rehabilitation of Pneumonectomy

Study on Standardization and Clinical Evaluation of Acupuncture and Drug Compound Technology to Accelerate Perioperative Rehabilitation of Pneumonectomy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Analgesia; Acupuncture Therapy; Perioperative Period; Pneumonectomy
• Intervention / Treatment: Device: Acupuncture and Drug Compound Technology; Other: Routine perioperative management

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.

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture and drug compound technology group; Routine perioperative management and transcutaneous electrical acupoints stimulation treatment	Device: Acupuncture and Drug Compound Technology; 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.; Other Names: Transcutaneous electrical acupoints stimulation treatment; Other: Routine perioperative management; 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.
Other: Control group; Routine perioperative management	Other: Routine perioperative management; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
First exhaust time after operation (h)	The time between the patient's first exhaust and the end of surgery will be recorded.	up to 1 week after surgery
First defecation time after operation (h)	The time between the patient's first defecation and the end of surgery will be recorded.	up to 1 week after surgery
Visual Analog Scale of Pain	Visual analogue scale of pain will be used to evaluate the pain level of the surgical incision, and the score will be recorded.The 10cm sliding scale has 10 scales on one side, and the two ends are respectively "0" and "10" points. A point of 0 means no pain, and a point of 10 means the most severe pain that is unbearable.	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)	Days between the day of discharge and surgery will be recorded.	up to 2 weeks after surgery
C-reactive protein (CRP,mg/L)	Inflammatory biomarker CRP will be determined by immunotransmission turbidimetry.	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.
Noradrenaline (NE,µg/L)	Stress response biomarker NE will be determined by immunotransmission turbidimetry.	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.
Postoperative stay time in the intensive care unit (h)	Record the time between the day of patient transfer from the ICU and the end of surgery.	up to 1 week after surgery
Postoperative antibiotics use days (d)	Duration of postoperative antibiotics use will be recorded	up to 1 week after surgery
Inpatient medical expenses	Record expenses incurred during the patient's hospitalization	up to 2 weeks after surgery

Collaborators and Investigators

• Sponsor: Shanghai Yueyang Integrated Medicine Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 14, 2021

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Pneumonectomy; Acupuncture Therapy; Perioperative Recovery
• Other Study ID Numbers: 20210421

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No