Transcutaneous Acupoint Electrical Stimulation and Postoperative Delirium Delirium

Delirium, Postoperative Clinical Trial

Official title:

Observing the Influence of Transcutaneous Acupoint Electrical Stimulation on Postoperative Delirium After Thoracoscopic Lung Resection Surgery - a Multicenter Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06318351
• Other study ID #: TJ-IRB202402015
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: August 30, 2025

Study information

• Verified date: April 2024
• Source: Tongji Hospital
• Contact: Xiao Ran, phd
• Phone: 15926207366
• Email: ranxiao1001[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 476
• Est. completion date: August 30, 2025
• Est. primary completion date: December 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Delirium, Postoperative
• Emergence Delirium

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Guangdong Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Qin Zhang	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium	Mini-Mental State Examination, MMSE	7days
Secondary	Recovery	Questionnaire	7days