Effect of Percutaneous Acupoint Electrical Stimulation on Delirium

Effect of Percutaneous Acupoint Electrical Stimulation on Delirium After Thoracoscopic Pneumonectomy

This study is a multicenter, prospective, randomized controlled clinical trial that aims to observe the impact of Transcutaneous Electrical Acupoint Stimulation (TEAS) on plasma TK/MMP3 in a randomized controlled setting. The intervention group received percutaneous acupoint electrical stimulation, whereas the control group underwent conventional treatment. The primary objective is to enhance the management of postoperative delirium, specifically focusing on the occurrence and severity of delirium following thoracoscopic pulmonary resection. Additionally, various perioperative inflammatory markers, cognitive function, recovery quality, pain levels, anxiety, sleep patterns, postoperative complications, and overall hospital stay duration were monitored to elucidate the mechanisms through which percutaneous acupoint electrical stimulation improves postoperative delirium.

Study Overview

• Status: Recruiting
• Conditions: Delirium, Postoperative
• Intervention / Treatment: Device: Transcutaneous Electrical Acupoint Stimulation

Detailed Description

Transcutaneous Electrical Acupoint Stimulation (TEAS) is a treatment method that combines acupuncture point theory of traditional Chinese medicine with physical electrical stimulation techniques. It achieves the purpose of acupoint stimulation by applying a weak current to a specific part. Compared with traditional acupuncture, TEAS has the advantages of non-invasiveness, safety, portability and adjustability. Intraoperative acupoint electrical stimulation has no effect on operation and monitoring.

This multicenter, prospective, randomized controlled clinical trial aims to investigate the impact of Transcutaneous Electrical Acupoint Stimulation (TEAS) on postoperative delirium following thoracoscopic pulmonary resection. The study design involves the randomized allocation of participants into two groups: an intervention group receiving percutaneous acupoint electrical stimulation and a control group undergoing standard postoperative care.

The intervention protocol includes the precise selection of acupoints for TEAS application, parameters for electrical stimulation, frequency of treatments, and duration of intervention sessions. Patients in the control group will receive conventional postoperative management without TEAS.

Outcome measures will assess plasma TK/MMP3 levels, incidence and severity of postoperative delirium, perioperative inflammatory markers, cognitive function, pain levels, anxiety, sleep patterns, postoperative complications, recovery quality, and hospital stay duration. Statistical analysis will employ appropriate methods to evaluate the effectiveness of TEAS in managing postoperative delirium.

Overall, this clinical trial seeks to contribute to the understanding of how TEAS may improve postoperative delirium management and patient outcomes following thoracoscopic pulmonary resection. The Detailed Description provides a comprehensive overview of the study protocol without duplicating information presented elsewhere in the document.

• Study Type: Interventional
• Enrollment (Estimated): 238
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiao Ran, phd; Phone Number: 15926207366; Email: ranxiao1001@tjh.tjmu.edu.cn
• Study Contact Backup: Name: Qin Zhang, phd; Phone Number: 15726207366; Email: qzhang8@tjh.tjmu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Not yet recruiting
      • Guangdong Hospital of Traditional Chinese Medicine
      • Contact: Jiemin Deng; Phone Number: 2780; Email: qin4298@sina.com
      • Contact: Jiemin Deng
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Qin Zhang, phd; Phone Number: 15717154768; Email: qzhang8@tjh.tjmu.edu.cn
      • Principal Investigator: Qin Zhang, phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Voluntary participation in the study;
• Age ≥ 18 years;
• Patients scheduled for thoracoscopic lung resection surgery;
• ASA grade I-III.

Exclusion Criteria:

• History of severe central nervous system diseases, psychiatric disorders, cognitive impairment, intellectual disability, or Mini-Mental State Examination (MMSE) score ≤23;
• History of opioid addiction, long-term use of analgesic drugs, or psychotropic drugs;
• Severe cardiovascular and cerebrovascular diseases;
• Severe liver and kidney dysfunction: Child-Pugh grade B, C patients, patients requiring regular dialysis, etc.;
• Pregnant or postpartum women;
• Patients with language communication barriers;
• Deemed unsuitable for participation by the researchers.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional treatment group; • Intrabronchial general anesthesia was used for anesthesia in all patients. Electrocardiogram (ECG), pulse oxygen saturation (SpO2), blood pressure (BP), body temperature (T), end-expiratory carbon dioxide (EtCO2), ventilators related parameters (VT, f, MV, etc.), and EEG monitoring (BIS) were routinely monitored during the operation.
Experimental: Percutaneous acupoint electrical stimulation treatment group; On the basis of the conventional treatment received by the control group, the following additional treatments were implemented: Patients assigned to the treatment group underwent acupuncture with electrode pieces placed on bilateral Sanyin jiao, bilateral Zusanli, bilateral Shenmen, Shenting, Yintang, bilateral Hegu, and bilateral Neiguan 30 minutes before anesthesia. The acupuncture involved electrical stimulation using a dense wave with a frequency of 2/100Hz. The stimulation intensity was adjusted to the maximum current tolerable by the patient, typically ranging from 1-7mA, and continued until the conclusion of the operation.	Device: Transcutaneous Electrical Acupoint Stimulation; Transcutaneous Electrical Acupoint Stimulation (TEAS) is a treatment that combines acupoint theory of traditional Chinese medicine with modern electrical stimulation techniques. It achieves the purpose of acupoint stimulation by applying a weak current to a specific part. TEAS operate just like ordinary electrodes with non-invasive, safe, portable, adjustable and other advantages.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium (using the Delirium Rating Scale, DRS)	The Delirium Rating Scale (DRS) is a validated instrument used to assess the severity of delirium in individuals. The DRS total score ranges from 0 to 46, with higher scores indicating greater severity of delirium symptoms.	Recovery period, 24 hours after surgery, 72 hours after surgery, 7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini-Mental State Examination (MMSE)	The Mini-Mental State Examination (MMSE) is a widely used cognitive screening tool that assesses various cognitive functions, including orientation, memory, attention, and language. The total score ranges from 0 to 30, with higher scores indicating better cognitive function.	Recovery period, 24 hours after surgery, 72 hours after surgery, 7 days after surgery

Collaborators and Investigators

• Sponsor: Qin Zhang
• Collaborators: National Natural Science Foundation of China
• Investigators: Principal Investigator: QIN Zhang, phd, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: April 6, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Delirium; Thoracoscopic lung resection surgery
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: TJ-IRB202403019

Drug and device information, study documents

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