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

Not Applicable

Not yet recruiting

• Conditions: Postoperative Delirium; Chronic Post Operative Pain; Postoperative Cognitive Dysfunction
• Interventions: Device: transaricular vagus nerve stimulation; Device: fake transaricular vagus nerve stimulation

• Registration Number: NCT05439707
• Lead Sponsor: Xuzhou Central Hospital

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.

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-06-26
• Study First Posted: 2022-06-30
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-09-30
• Study Start: 2022-10-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	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.
Control group	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.

Primary Outcome Measures

Name	Time	Method
Postoperative cognitive function	3 months after the surgery.	The incidence of POCD was compared between the experimental group and the control group.The preoperative and postoperative differences of the following scales were calculated and compared: Digit Span (forward and backward), Visual Retention and Paired Associate Verbal Learning subtests of the Wechsler Memory Scale, Digit Symbol subtest of the Wechsler Adult Intelligence ScaleRevised, Halstead-Reitan Trail Making Test (Part A), Corsi Block Test and Grooved Pegboard Test (favored and unfavored hand). The standard deviation (SD) for each test was computed from the preoperative scores. A participant whose postoperative performance declined by ≥1 SD as compared to each preoperative test score on ≥2 tests was classified as POCD.
Acute postoperative pain	Consecutive 7 days after the surgery for acute pain	The incidence of acute postoperative pain was compared between the experimental group and the control group.Acute postoperative pain was assessed by Visual Analogue Scale(VAS) for 7 consecutive days within 1 week after surgery.
Postoperative delirium	Consecutive 7 days after the surgery	The incidence of POD was compared between the experimental group and the control group.Postoperative delirium was assessed by the Delirium Assessment Scale (CAM-ICU)
Chronic Postsurgical pain	3 months after the surgery for chronic pain	The incidence of chronic postoperative pain (CPSP) was assessed by the Short Form McGill Pain Questionnaire (SF-MPQ) and Neuropathic Pain Scale (NPS).The incidence of CPSP was compared between the experimental group and the control group.

Secondary Outcome Measures

Name	Time	Method
cortisol level in peripheral venous blood	1 day before the surgery, Postoperative day 1, 3, 5	The incidence of cortisol level (μg/dL) in peripheral venous blood was compared between the experimental group and the control group
TNF-α level in peripheral venous blood	1 day before the surgery, Postoperative day 1, 3, 5	The incidence of TNF-α level (pg/ml) in peripheral venous blood was compared between the experimental group and the control group
IL-6 level in peripheral venous blood	1 day before the surgery, Postoperative day 1, 3, 5	The incidence of IL-6 level (pg/ml) in peripheral venous blood was compared between the experimental group and the control group
IL-1β level in peripheral venous blood	1 day before the surgery, Postoperative day 1, 3, 5	The incidence of IL-1β level (pg/ml) in peripheral venous blood was compared between the experimental group and the control group

Trial Locations

Locations (1)

Xuzhou Central Hospital; 🇨🇳 Changzhou, Jiangsu, China