Clinical trial NCT06360549: Effect of Percutaneous Acupoint Electrical Stimulation on Delirium
Official title: Effect of Percutaneous Acupoint Electrical Stimulation on Delirium After Thoracoscopic Pneumonectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Delirium, Postoperative
Keywords: Delirium
Thoracoscopic lung resection surgery
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2024-04-11
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention group was percutaneous acupoint electrical stimulation treatment group, and the control group was conventional treatment group.

Inclusion criteria:

1. Voluntarily sign informed consent;
2. Age ≥18 years old;
3. Patients undergoing thoracoscopic pneumonectomy;
4. ASA Grade I-III;
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Delirium (using the Delirium Rating Scale, DRS)
timeFrame: Recovery period, 24 hours after surgery, 72 hours after surgery, 7 days after surgery
Secondary outcomes:
measure: Mini-Mental State Examination (MMSE)
timeFrame: Recovery period, 24 hours after surgery, 72 hours after surgery, 7 days after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Hospital of Traditional Chinese Medicine
state: Guangdong
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Qin Zhang, phd
role: PRINCIPAL_INVESTIGATOR
References: