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Clinical Trials/NCT06161662
NCT06161662
Completed
Not Applicable

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

Zhihong LU1 site in 1 country226 target enrollmentJanuary 10, 2024

Overview

Phase
Not Applicable
Intervention
transcutaneous electrical acupoint stimulation
Conditions
Anesthesia
Sponsor
Zhihong LU
Enrollment
226
Locations
1
Primary Endpoint
Incidence of delirium by 7 days after surgery
Status
Completed
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 10, 2024
End Date
January 30, 2025
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Zhihong LU
Responsible Party
Sponsor Investigator
Principal Investigator

Zhihong LU

Associate professor

Air Force Military Medical University, China

Eligibility Criteria

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

Arms & Interventions

Transcutaneous electrical 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.

Intervention: transcutaneous electrical acupoint stimulation

Control

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

Intervention: Control

Outcomes

Primary Outcomes

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

  • Incidence of delirium by 1 day after surgery(From end of surgery to 1 day after surgery)
  • Maximal decrease of regional cerebral oxygen saturation(From anesthesia induction to the end of surgery)
  • Incidence of delirium by 3 days after surgery(From end of surgery to 3 days after surgery)
  • electroencephalogram (EEG) alpha band power(From anesthesia induction to the end of surgery)
  • opioid consumption for patient controlled analgesia(From end of surgery to 1 day after 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)
  • The numerical rating scale of sleep quality(From end of surgery to 3 days after surgery)
  • The numerical rating scale of pain(From end of surgery to 3 days after surgery)
  • The Quality of Recovery-15 Score by 3 days after surgery(From end of surgery to 3 days after surgery)
  • number of attempts for patient controlled analgesia(From end of surgery to 1 day after surgery)
  • total sleep time(From end of surgery to 1 day after surgery)

Study Sites (1)

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