Effect of Percutaneous Acupoint Electrical Stimulation on Delirium

NCT ID: NCT06360549

Last Updated: 2024-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Delirium, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Transcutaneous Electrical Acupoint Stimulation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

Qin Zhang

OTHER

Sponsor Role lead

Responsible Party

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Qin Zhang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Qin Zhang, phd

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

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Guangdong Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiao Ran, phd

Role: CONTACT

15926207366

Qin Zhang, phd

Role: CONTACT

15726207366

Facility Contacts

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Jiemin Deng

Role: primary

Jiemin Deng

Role: backup

Qin Zhang, phd

Role: primary

15717154768

Other Identifiers

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TJ-IRB202403019

Identifier Type: -

Identifier Source: org_study_id

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