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

Xuzhou Central Hospital (Xuzhou Fourth People's Hospital)

Status: Not yet enrolling

Conditions: Chronic Post Operative Pain; Postoperative Delirium; Postoperative Cognitive Dysfunction

Treatments: Device: fake transaricular vagus nerve stimulation; Device: transaricular vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05439707

XuzhouCH20220620

Details and patient eligibility

About

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.

Full description

The investigators assessed POD by the Confusion Assessment Method for the ICU twice daily for 7 days after surgery. Participants' cognitive function was assessed with neuropsychological battery tests. The tests included digit span (forward and backward), Corsi block, paired associate verbal learning, digit symbol test, trail-making test and so on.The investigators make a CPSP diagnosis based on the 11th revision of the International Classification of Diseases.

Enrollment: 600 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 50 to 80 years old.
• ASA grade I-Ⅲ.
• elective knee or hip replacement.

Exclusion criteria

• Mini-Mental State Examination (MMSE) score < 23.
• Education years<7.
• Peptic ulcer disease, serious cardiac-cerebral vascular disease.
• Neurological or psychiatric disorders.
• History of drug and alcohol abuse.
• Hepatic and/or kidney dysfunction.
• BMI>35.
• Patients on antidepressants.
• ASA >Ⅲ.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups

Experimental group

Experimental group

Description:

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.

Treatment:

Device: transaricular vagus nerve stimulation

Control group

Sham Comparator group

Description:

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.

Treatment:

Device: fake transaricular vagus nerve stimulation