Transcutaneous Acupoint Electrical Stimulation and Postoperative Delirium Delirium

Recruiting

• Conditions: Delirium, Postoperative
• Interventions: Procedure: transcutaneous acupoint electrical stimulation

• Registration Number: NCT06318351
• Lead Sponsor: Qin Zhang

Brief 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.

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 Timeline

• Study Start: 2024-02-01
• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-18
• Study First Posted: 2024-03-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-06
• Last Update Posted: 2024-04-09
• Primary Completion: 2024-12-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 476

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transcutaneous Electrical Acupoint Stimulation	transcutaneous acupoint electrical stimulation	The effect of Transcutaneous Electrical Acupoint Stimulation on postoperative vision was observed according to anesthesiologist's habit of using or not using it.

Primary Outcome Measures

Name	Time	Method
Delirium	7days	Mini-Mental State Examination, MMSE

Secondary Outcome Measures

Name	Time	Method
Recovery	7days	Questionnaire

Trial Locations

Locations (2)

Guangdong Hospital of Traditional Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China