Effect of Percutaneous Acupoint Electrical Stimulation on Delirium
NCT ID: NCT06360549
Last Updated: 2024-04-11
Study Results
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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RECRUITING
NA
238 participants
INTERVENTIONAL
2024-03-01
2025-06-30
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
Inclusion criteria:
1. Voluntarily sign informed consent;
2. Age ≥18 years old;
3. Patients undergoing thoracoscopic pneumonectomy;
4. ASA Grade I-III;
TREATMENT
QUADRUPLE
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years;
* Patients scheduled for thoracoscopic lung resection surgery;
* ASA grade I-III.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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National Natural Science Foundation of China
OTHER_GOV
Qin Zhang
OTHER
Responsible Party
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Qin Zhang
Professor
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
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Jiemin Deng
Role: backup
Other Identifiers
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TJ-IRB202403019
Identifier Type: -
Identifier Source: org_study_id
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