- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06318351
Transcutaneous Acupoint Electrical Stimulation and Postoperative Delirium Delirium
Observing the Influence of Transcutaneous Acupoint Electrical Stimulation on Postoperative Delirium After Thoracoscopic Lung Resection Surgery - a Multicenter Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Xiao Ran, phd
- Phone Number: 15926207366
- Email: ranxiao1001@tjh.tjmu.edu.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Not yet recruiting
- Guangdong Hospital of Traditional Chinese Medicine
-
Contact:
- Jiemin Deng
- Phone Number: 2780
- Email: qin4298@sina.com
-
Contact:
- Jiemin Deng
-
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Hubei
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Wuhan, Hubei, China, 430030
- Recruiting
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
Contact:
- Qin Zhang, phd
- Phone Number: 15717154768
- Email: qzhang8@tjh.tjmu.edu.cn
-
Principal Investigator:
- Qin Zhang, phd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Delirium
Time Frame: 7days
|
Mini-Mental State Examination, MMSE
|
7days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recovery
Time Frame: 7days
|
Questionnaire
|
7days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Qin Zhang, phd, Tongji Medical College, Huazhong University of Science and Technology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TJ-IRB202402015
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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