Effects of Perioperative Transauricular Vagus Nerve Electrical Stimulation on POD, POCD and CPSP

Summary

Postoperative delirium (POD) and postoperative cognitive dysfunction (POCD) occur in 11-51% of patients after surgery, and its prevalence increases with age. The occurrence of delirium is associated with increased morbidity and mortality, prolonged hospital stay, worse functional recovery. Orthopedic procedures and specifically joint replacements have been considered as a major risk for development of chronic postsurgical pain (CPSP). Approximately 13-44% of patients will develop CPSP after knee or hip arthOpioid abuseroplasty. CPSP may cause the discomfort, distress, disability and opioid abuse. Mounting evidence has revealed that inflammation triggered by surgical trauma plays a key role in POD, POCD and CPSP. Recent studies found that vagus nerve stimulation showed the suppression of inflammation. In this study, the effect of perioperative transauricular vagus nerve stimulation on the prognosis of patients undergoing arthroplasty will be investigated, providing potential solutions for the prevention and treatment of postoperative cognitive dysfunction, postoperative delirium and chronic postsurgical pain.

Conditions

• Postoperative Cognitive Dysfunction
• Postoperative Delirium
• Chronic Post Operative Pain

Interventions

DEVICE

transaricular vagus nerve stimulation

The transaricular vagus nerve stimulator was placed in the left ear trunk, which is dominated only by the auricular branch of the vagus nerve. Continuous stimulation was performed at a frequency of 25Hz with pulse width of 300 μs. The stimulation was adjusted to be higher than the perception threshold and lower than the pain threshold. Each stimulation lasted for 30 minutes, three times per day (morning, noon, evening), from 1 day before surgery to 7 days after surgery, and the treatment lasted for 9 consecutive days.

DEVICE

fake transaricular vagus nerve stimulation

The transaricular vagus nerve stimulator was placed in the same position as the experimental group, covered with an insulating film and placed at the site of the stimulation, so that the patient could not actually receive the electrical stimulation. Continuous stimulation was performed at a frequency of 25Hz and pulse width of 300 μs, and the stimulation was adjusted to be higher than the perception threshold and lower than the pain threshold. Each stimulation lasted for 30 minutes, three times per day (morning, noon, evening), from 1 day before surgery to 7 days after surgery, for 9 consecutive days.

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University

  collaborator OTHER

• The First People's Hospital of Xuzhou

  collaborator OTHER

• Xuzhou Central Hospital

  lead OTHER

Principal Investigators

• Yangzi Zhu, Doctor · Xuzhou Central Hospital

• Liwei Wang, Doctor · Xuzhou Central Hospital

• Junli Cao, PhD & MD · Xuzhou Medical University

• Daqing Ma, PhD & MD · Imperial College London

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-01

Primary Completion

2024-07-01

Completion

2024-09-01

Countries

• China

Study Locations