Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06318351
Other study ID # TJ-IRB202402015
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06392308 - The Impact of Smoking on the Prognosis of Elderly Surgical Patients
Completed NCT06302517 - Bis Monitoring Effect on Delirium Occurrence and Nursing Quality Improvement Recovering From General Anesthesia N/A
Recruiting NCT06090955 - Modulating Surgery-Induced Blood-Brain Barrier Disruption in Elderly N/A
Recruiting NCT06052397 - Sleep and Circadian Rhythm Biomarkers of Postoperative Delirium
Not yet recruiting NCT06107517 - DREAMS-OT Trial: Delirium Reduction Through Early Activation in Motivating and Sleep Promoting Routines: A Randomized Controlled Trial of Occupational Therapy for ICU Patients After Coronary Artery Bypass Graft (CABG) Surgery N/A
Completed NCT04563858 - Polish Validation 4AT Tool
Completed NCT06268119 - Effectiveness of Delirium Care Protocol After Cardiac Surgery N/A
Not yet recruiting NCT06268080 - Depth of Anesthesia on Postoperative Delirium and Cognitive After Surgery N/A
Recruiting NCT06360549 - Effect of Percutaneous Acupoint Electrical Stimulation on Delirium N/A
Completed NCT06187389 - Validation and Reliability of the Turkish 4AT Scale for Post-Anesthesia Awakening Delirium
Recruiting NCT01283412 - Dexmedetomidine on Postoperative Delirium and Quality of Recovery in Geriatric Patients Phase 3
Recruiting NCT06318364 - Postoperative Delirium in the Post-anesthesia Care Unit
Completed NCT01032161 - Perioperative Risk Factors for Postoperative Delirium in Children N/A
Completed NCT05942183 - Optic Nerve Sheath Diameter is Associated With Postoperative Delirium in Patients Undergoing Open Heart Surgery
Not yet recruiting NCT06361238 - Liraglutide in Preventing Delirium in Diabetic Elderly After Cardiac Surgery Phase 3
Not yet recruiting NCT06346990 - The Effect of Listening to Holy Quran Recital on the Incidence of Delirium Post-CABG N/A