Clinical trial NCT05439707: Effects of Perioperative Transauricular Vagus Nerve Electrical Stimulation on POD, POCD and CPSP
Official title: Effects of Perioperative Transauricular Vagus Nerve Electrical Stimulation on Postoperative Delirium, Postoperative Cognitive Dysfunction and Chronic Postsurgical Pain in Patients Undergoing Arthroplasty.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Cognitive Dysfunction
Postoperative Delirium
Chronic Post Operative Pain
Lead sponsor: Xuzhou Central Hospital
Sponsor class: OTHER
Collaborators: name: The Affiliated Hospital of Xuzhou Medical University
name: The First People's Hospital of Xuzhou
First posted: 2022-06-30
Enrollment: 600
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative cognitive function
timeFrame: 1 month after the surgery.
measure: Postoperative cognitive function
timeFrame: 3 months after the surgery.
measure: Postoperative delirium
timeFrame: Consecutive 7 days after the surgery
measure: Acute postoperative pain
timeFrame: Consecutive 7 days after the surgery for acute pain
measure: Chronic Postsurgical pain
timeFrame: 3 months after the surgery for chronic pain
Secondary outcomes:
measure: TNF-α level in peripheral venous blood
timeFrame: 1 day before the surgery, Postoperative day 1, 3, 5
measure: IL-6 level in peripheral venous blood
timeFrame: 1 day before the surgery, Postoperative day 1, 3, 5
measure: IL-1β level in peripheral venous blood
timeFrame: 1 day before the surgery, Postoperative day 1, 3, 5
measure: cortisol level in peripheral venous blood
timeFrame: 1 day before the surgery, Postoperative day 1, 3, 5
Other outcomes:
Locations:
city: Changzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
Study officials:
affiliation: Xuzhou Central Hospital
name: Yangzi Zhu, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Xuzhou Central Hospital
name: Liwei Wang, Doctor
role: STUDY_DIRECTOR
affiliation: Xuzhou Medical University
name: Junli Cao, PhD & MD
role: STUDY_CHAIR
affiliation: Imperial College London
name: Daqing Ma, PhD & MD
role: STUDY_CHAIR
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