Clinical trial NCT06161662: Effect of Acupoint Stimulation on Postoperative Delirium and Electroencephalogram
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Delirium and EEG Characteristic Parameters in Elderly Patients Undergoing Abdominal Surgery Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anesthesia
Postoperative Delirium
Electroencephalogram
Keywords: Transcutaneous electrical acupoint stimulation
Postoperative delirium
Electroencephalogram
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 226
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of delirium by 7 days after surgery
timeFrame: from end of surgery to 7 days after surgery
Secondary outcomes:
measure: maximal electroencephalogram (EEG) alpha band power reduction
timeFrame: From anesthesia induction to the end of surgery
measure: Maximal decrease of regional cerebral oxygen saturation
timeFrame: From anesthesia induction to the end of surgery
measure: EEG explosive suppression time
timeFrame: From anesthesia induction to the end of surgery
measure: Incidence of major neurological complications
timeFrame: From end of surgery to discharge from hospital, at an average of 7 days
measure: The Athens Insomnia Scale and Epworth somnolence Scale score by 1 day after surgery
timeFrame: From end of surgery to 1 day after surgery
measure: The Athens Insomnia Scale and Epworth somnolence Scale score by 3 days after surgery
timeFrame: From end of surgery to 3 days after surgery
measure: The Hospital Anxiety and Depression Scales by 1 day after surgery
timeFrame: From end of surgery to 1 day after surgery
measure: The Hospital Anxiety and Depression Scales by 3 days after surgery
timeFrame: From end of surgery to 3 days after surgery
measure: The Quality of Recovery-15 Score by 1 day after surgery
timeFrame: From end of surgery to 1 day after surgery
measure: The Quality of Recovery-15 Score by 3 days after surgery
timeFrame: From end of surgery to 1 day after surgery
measure: Incidence of delirium by 1 day after surgery
timeFrame: From end of surgery to 1 day after surgery
measure: Incidence of delirium by 3 days after surgery
timeFrame: From end of surgery to 3 days after surgery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: the First Affiliated Hospital of the Air Force Military Medical University
state: Shaanxi
Study officials:
References:
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.
citation: 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.