Transcutaneous Acupoint Electrical Stimulation and Postoperative Delirium Delirium

NCT ID: NCT06318351

Last Updated: 2024-04-09

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

Total Enrollment

476 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-08-30

Brief Summary

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Investigating postoperative delirium in patients undergoing thoracoscopic lung resection surgery who have received or not received relevant transcutaneous acupoint electrical stimulation treatment preoperatively, observing postoperative recovery quality indicators, evaluating the necessity of treatment, and clarifying the potential mechanisms by which transcutaneous acupoint electrical stimulation may improve postoperative delirium.

Detailed Description

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Research design type: multicenter, prospective, cohort observational trial. The leading unit is Tongji Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology, and the participating unit is Guangdong Provincial Hospital of Chinese Medicine (a large comprehensive traditional Chinese medicine hospital directly under the National Administration of Traditional Chinese Medicine), skilled in using traditional Chinese medicine treatment methods to improve postoperative recovery quality. Participating in a multicenter clinical study on transcutaneous acupoint electrical stimulation to improve postoperative delirium after thoracoscopic surgery will help collectively explore the perioperative application and mechanism of action of traditional Chinese medicine techniques for acupoint stimulation.

Firstly, patients meeting the inclusion criteria from the Department of Thoracic Surgery of Tongji Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology and Guangdong Provincial Hospital of Chinese Medicine will be recruited. Upon admission, the Mini-Mental State Examination (MMSE) will be used as a routine clinical assessment to screen all patients for cognitive status to reduce the impact of cognitive impairments on subsequent observations. Subsequently, based on whether patients receive transcutaneous acupoint electrical stimulation treatment by an anesthesiologist, patients will be divided into two groups (yes or no for receiving the treatment). Their recovery period, delirium assessment within 7 days postoperatively, as well as assessments of sleep, pain, etc., will be observed. Preoperative and postoperative peripheral blood samples will be collected for testing related indicators. Information on demographic characteristics, discharge diagnosis, laboratory indicators at admission and discharge, postoperative complications, length of hospital stay, disease awareness, etc., will be collected from the medical records system for statistical analysis to explore the correlation between transcutaneous acupoint electrical stimulation and postoperative delirium in patients undergoing thoracoscopic lung resection.

Conditions

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Delirium, Postoperative

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Transcutaneous Electrical Acupoint Stimulation

The effect of Transcutaneous Electrical Acupoint Stimulation on postoperative vision was observed according to anesthesiologist's habit of using or not using it.

transcutaneous acupoint electrical stimulation

Intervention Type PROCEDURE

This is a safe and non-invasive procedure, similar to an electrode sheet, which applies a weak current to a specific site to achieve the purpose of acupoint stimulation.

Interventions

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transcutaneous acupoint electrical stimulation

This is a safe and non-invasive procedure, similar to an electrode sheet, which applies a weak current to a specific site to achieve the purpose of acupoint stimulation.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. History of severe central nervous system diseases, psychiatric disorders, cognitive impairment, intellectual disability, or Mini-Mental State Examination (MMSE) score ≤23;
2. History of opioid addiction, long-term use of analgesic drugs, or psychotropic drugs;
3. Severe cardiovascular and cerebrovascular diseases;
4. Severe liver and kidney dysfunction: Child-Pugh grade B, C patients, patients requiring regular dialysis, etc.;
5. Pregnant or postpartum women;
6. Patients with language communication barriers;
7. 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 Medical College, Huazhong University of Science and Technology

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

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-IRB202402015

Identifier Type: -

Identifier Source: org_study_id

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