Effect of Acupoint Stimulation on Postoperative Delirium and Electroencephalogram

Anesthesia Clinical Trial

— AS-DEEP  

Official title:

Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Delirium and EEG Characteristic Parameters in Elderly Patients Undergoing Abdominal Surgery Under General Anesthesia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06161662
• Other study ID #: XJH-A-20230920
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 10, 2023
• Est. completion date: June 1, 2026

Study information

• Verified date: November 2023
• Source: Air Force Military Medical University, China
• Contact: Lu Zhihong, Ph,D
• Phone: +862984775343
• Email: deerlu23[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Transcutaneous electrical acupoint stimulation (TEAS) was reported to benefit the patients undergoing surgeries by reducing anesthetics consumption and decreasing anesthesia related adverse effects. Electroencephalogram (EEG) and EEG-related indicators are important indicators reflecting the conscious state of the brain, and different anesthetic drugs and anesthesia depths cause different EEG characteristic changes. The mechanism by which TEAS improves postoperative delirium (POD) is not clear, and whether changes in EEG characteristic parameters is involved needs to be further explored. Therefore, this study aims to observe the effect of TEAS at Neiguan and Shenmen acupoint on POD in elderly patients undergoing abdominal surgery, and to explore the EEG related mechanism underlying TEAS improving POD.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 226
• Est. completion date: June 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. aged 65 years or older

2. American Society of Anesthesiologists (ASA) classification= Grade III

3. Patients scheduled for elective abdominal surgery under general anesthesia

4. Informed consent

Exclusion Criteria:

1. Patients with severe central nervous system injury or severe cerebrovascular disease

2. Patients with cognitive dysfunction assessed by Confusion Assessment Method before surgery

3. Patients unable to cooperate with studies, such as psychiatric disorders or difficulty in communication

4. Patients with severe hepatic and renal insufficiency

5. Patients with severe respiratory diseases

6. Patients with contraindication for transcutaneous electrical stimulation, such as implanted electrophysiological devices, skin infection and damage at acupuncture points

7. Anticipated duration of anesthesia shorter than 2 hours or postoperative hospital stay shorter than 3 days

Related Conditions & MeSH terms

• Anesthesia
• Delirium
• Electroencephalogram
• Emergence Delirium
• Postoperative Delirium

Intervention

Other:
• transcutaneous electrical acupoint stimulation
Electrodes will be attached on the surface of acupoints and electrical stimulation will be given
• Control
Electrodes will be attached on the surface of acupoints but no stimulation will be given

Locations

Country	Name	City	State
China	the First Affiliated Hospital of the Air Force Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Zhihong LU

Country where clinical trial is conducted

China, 

References & Publications (2)

Feng B, Zhang Y, Luo LY, Wu JY, Yang SJ, Zhang N, Tan QR, Wang HN, Ge N, Ning F, Zheng ZL, Zhu RM, Qian MC, Chen ZY, Zhang ZJ. Transcutaneous electrical acupoint stimulation for post-traumatic stress disorder: Assessor-blinded, randomized controlled study. Psychiatry Clin Neurosci. 2019 Apr;73(4):179-186. doi: 10.1111/pcn.12810. Epub 2019 Jan 22. — View Citation

Guay CS, Kafashan M, Huels ER, Jiang Y, Beyoglu B, Spencer JW, Geczi K, Apakama G, Ju YS, Wildes TS, Avidan MS, Palanca BJA. Postoperative Delirium Severity and Recovery Correlate With Electroencephalogram Spectral Features. Anesth Analg. 2023 Jan 1;136(1):140-151. doi: 10.1213/ANE.0000000000006075. Epub 2022 May 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of delirium by 7 days after surgery	Delirium will be assessed by 3-minute Diagnostic Interview for Confusion Assessment Method	from end of surgery to 7 days after surgery
Secondary	maximal electroencephalogram (EEG) alpha band power reduction		From anesthesia induction to the end of surgery
Secondary	Maximal decrease of regional cerebral oxygen saturation		From anesthesia induction to the end of surgery
Secondary	EEG explosive suppression time	EEG burst suppression is defined as a burst-suppression ratio (BSR) = 10%, more than 1 minute	From anesthesia induction to the end of surgery
Secondary	Incidence of major neurological complications	Coma, stroke, altered state of consciousness	From end of surgery to discharge from hospital, at an average of 7 days
Secondary	The Athens Insomnia Scale and Epworth somnolence Scale score by 1 day after surgery		From end of surgery to 1 day after surgery
Secondary	The Athens Insomnia Scale and Epworth somnolence Scale score by 3 days after surgery		From end of surgery to 3 days after surgery
Secondary	The Hospital Anxiety and Depression Scales by 1 day after surgery		From end of surgery to 1 day after surgery
Secondary	The Hospital Anxiety and Depression Scales by 3 days after surgery		From end of surgery to 3 days after surgery
Secondary	The Quality of Recovery-15 Score by 1 day after surgery		From end of surgery to 1 day after surgery
Secondary	The Quality of Recovery-15 Score by 3 days after surgery		From end of surgery to 1 day after surgery
Secondary	Incidence of delirium by 1 day after surgery		From end of surgery to 1 day after surgery
Secondary	Incidence of delirium by 3 days after surgery		From end of surgery to 3 days after surgery