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Completed

NCT Number: NCT06161662

STimulation Electronically of Acupoints for Postoperative Delirium in elderlY Patients

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the First Affiliated Hospital of the Air Force Military Medical University

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

transcutaneous electrical acupoint stimulation

Other

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

Other names: TEAS

Control

Other

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

Primary outcomes

  1. Incidence of delirium by 7 days after surgery

    Time frame: from end of surgery to 7 days after surgery

    Delirium will be assessed by 3-minute Diagnostic Interview for Confusion Assessment Method

Secondary outcomes

  1. electroencephalogram (EEG) alpha band power

    Time frame: From anesthesia induction to the end of surgery

  2. Maximal decrease of regional cerebral oxygen saturation

    Time frame: From anesthesia induction to the end of surgery

  3. Incidence of major complications

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

    myocardial ischemia needing intervention, heart failure, respiratory failure, pneumonia, Coma, stroke, altered state of consciousness

  4. The numerical rating scale of sleep quality

    Time frame: From end of surgery to 1 day after surgery

    The scale is from 0 to 10. 0 is the worst sleep quality, 10 is the best sleep quality

  5. The numerical rating scale of pain

    Time frame: From end of surgery to 1 day after surgery

    The scale is from 0 to 10. 0 is no pain, 10 is the worst pain

  6. The numerical rating scale of sleep quality

    Time frame: From end of surgery to 3 days after surgery

    The scale is from 0 to 10. 0 is the worst sleep quality, 10 is the best sleep quality

  7. The numerical rating scale of pain

    Time frame: From end of surgery to 3 days after surgery

    The scale is from 0 to 10. 0 is no pain, 10 is the worst pain

  8. The Quality of Recovery-15 Score by 3 days after surgery

    Time frame: From end of surgery to 3 days after surgery

  9. Incidence of delirium by 1 day after surgery

    Time frame: From end of surgery to 1 day after surgery

  10. Incidence of delirium by 3 days after surgery

    Time frame: From end of surgery to 3 days after surgery

  11. opioid consumption for patient controlled analgesia

    Time frame: From end of surgery to 1 day after surgery

    the consumption is converted to morphine equivalence

  12. number of attempts for patient controlled analgesia

    Time frame: From end of surgery to 1 day after surgery

    number of patients pressing the bolus button of the patient controlled analgesia device, indicating that the patient feel pain

  13. total sleep time

    Time frame: From end of surgery to 1 day after surgery

Sponsors and collaborators

Lead sponsor

Zhihong LU

Other

Registry information

Official study title

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

Acronym: STEADY

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 8, 2023
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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