Effect of Acupoint Stimulation on Postoperative Delirium and Electroencephalogram

Not Applicable

Not yet recruiting

• Conditions: Anesthesia; Postoperative Delirium; Electroencephalogram
• Interventions: Other: Control; Other: transcutaneous electrical acupoint stimulation

• Registration Number: NCT06161662
• Lead Sponsor: Zhihong LU

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-30
• Study First Submitted QC: 2023-11-30
• Last Update Submitted: 2023-11-30
• Study First Posted: 2023-12-08
• Last Update Posted: 2023-12-08
• Study Start: 2023-12-10
• Primary Completion: 2025-12-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 226

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	At the beginning of anesthesia induction, the electrodes are attached to the skin at the Neiguan point and the Shenmen point without stimulation
Transcutaneous electrical stimulation	transcutaneous electrical acupoint stimulation	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.

Primary Outcome Measures

Name	Time	Method
Incidence of delirium by 7 days after surgery	from end of surgery to 7 days after surgery	Delirium will be assessed by 3-minute Diagnostic Interview for Confusion Assessment Method

Secondary Outcome Measures

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

Trial Locations

Locations (1)

the First Affiliated Hospital of the Air Force Military Medical University; 🇨🇳 Xi'an, Shaanxi, China