STimulation Electronically of Acupoints for Postoperative Delirium in elderlY Patients

NCT06161662 | Completed

• 1 other identifier: XJH-A-20230920
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Postoperative Delirium; Electroencephalogram

Keywords

Transcutaneous electrical acupoint stimulation; Postoperative delirium; Electroencephalogram

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• electroencephalogram (EEG) alpha band power

  From anesthesia induction to the end of surgery

• Maximal decrease of regional cerebral oxygen saturation

  From anesthesia induction to the end of surgery

• Incidence of major complications

  From end of surgery to discharge from hospital, at an average of 7 days

• The numerical rating scale of sleep quality

  From end of surgery to 1 day after surgery

• The numerical rating scale of pain

  From end of surgery to 1 day after surgery

Study Arms (2)

Transcutaneous electrical stimulation

EXPERIMENTAL

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.

Other: transcutaneous electrical acupoint stimulation

Control

OTHER

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

Other: Control

Interventions

transcutaneous electrical acupoint stimulation OTHER

Electrodes will be attached on the surface of acupoints and electrical stimulation will be given

Also known as: TEAS

Transcutaneous electrical stimulation

Control OTHER

Electrodes will be attached on the surface of acupoints but no stimulation will be given

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• aged 65 years or older
• American Society of Anesthesiologists (ASA) classification≤ Grade III
• Patients scheduled for elective abdominal surgery under general anesthesia
• Informed consent

You may not qualify if:

• Patients with severe central nervous system injury or severe cerebrovascular disease
• Patients with cognitive dysfunction assessed by Confusion Assessment Method before surgery
• Patients unable to cooperate with studies, such as psychiatric disorders or difficulty in communication
• Patients with severe hepatic and renal insufficiency
• Patients with severe respiratory diseases
• Patients with contraindication for transcutaneous electrical stimulation, such as implanted electrophysiological devices, skin infection and damage at acupuncture points
• Anticipated duration of anesthesia shorter than 2 hours or postoperative hospital stay shorter than 3 days

Sponsors & Collaborators

• Zhihong LU: lead

Study Sites (1)

the First Affiliated Hospital of the Air Force Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Related Publications (2)

• 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.

  PMID: 36130079 BACKGROUND

• 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.

  PMID: 30565342 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Four or six patients were defined as a block group and the results were sealed in envelopes using computer-generated block randomisation by a researcher not involved in clinical anesthesia. After the patients were enrolled, the study nurse opened the envelope according to the corresponding enrollment number and obtained the group results.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: January 10, 2024
• Primary Completion: October 8, 2024
• Study Completion: January 30, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: during 3 months and 5 years following article publication after deidentification

Locations

CN (1)