Effect of Acupoint Stimulation on Postoperative Delirium and Electroencephalogram (AS-DEEP)

Zhihong LU

Status: Not yet enrolling

Conditions: Electroencephalogram; Postoperative Delirium; Anesthesia

Treatments: Other: transcutaneous electrical acupoint stimulation; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT06161662

XJH-A-20230920

Details and patient eligibility

About

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.

Enrollment: 226 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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226 participants in 2 patient groups

Transcutaneous electrical stimulation

Experimental group

Description:

At the beginning of anesthesia induction, the electrodes are attached to the skin at the Neiguan point and Shenmen point and connected to the percutaneous acupoint electrical stimulation device (Hwato , Suzhou Medical Equipment Factory). Electrical stimulation is given.

Treatment:

Other: transcutaneous electrical acupoint stimulation

Control

Other group

Description:

At the beginning of anesthesia induction, the electrodes are attached to the skin at the Neiguan point and the Shenmen point without stimulation

Treatment:

Other: Control