Effect of Percutaneous Acupoint Electrical Stimulation on Delirium

NCT06360549 | Recruiting DMC

• 1 other identifier: TJ-IRB202403019
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 2

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.

Conditions

Delirium, Postoperative

Keywords

Delirium; Thoracoscopic lung resection surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mini-Mental State Examination (MMSE)

  Recovery period, 24 hours after surgery, 72 hours after surgery, 7 days after surgery

Study Arms (2)

Conventional treatment group

NO INTERVENTION

• 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.

Percutaneous acupoint electrical stimulation treatment group

EXPERIMENTAL

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

Interventions

Transcutaneous Electrical Acupoint Stimulation 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.

Percutaneous acupoint electrical stimulation treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qin Zhang: lead
• National Natural Science Foundation of China: collaborator

Study Sites (2)

Guangdong Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, 510000, China

NOT YET RECRUITING

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

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium; Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Qin Zhang, phd

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao Ran, phd

CONTACT

15926207366; ranxiao1001@tjh.tjmu.edu.cn

Qin Zhang, phd

CONTACT

15726207366; qzhang8@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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;

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: April 11, 2024
• Study Start: March 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

CN (2)