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

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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

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

Trial contacts and locations

1

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Central trial contact

Yangzi Zhu, Doctor; Rui Yao, Maser

Data sourced from clinicaltrials.gov

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