Effect of Percutaneous Acupoint Electrical Stimulation on Delirium

Delirium, Postoperative Clinical Trial

Official title:

Effect of Percutaneous Acupoint Electrical Stimulation on Delirium After Thoracoscopic Pneumonectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06360549
• Other study ID #: TJ-IRB202403019
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: Tongji Hospital
• Contact: Xiao Ran, phd
• Phone: 15926207366
• Email: ranxiao1001[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 238
• Est. completion date: June 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Delirium, Postoperative

Intervention

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.

Locations

Country	Name	City	State
China	Guangdong Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Qin Zhang	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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