Effects of Perioperative Transauricular Vagus Nerve Electrical Stimulation on POD, POCD and CPSP
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental group 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: 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.
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| Sham Comparator: Control group 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. |
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.
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Outcome Measures
Primary Outcome Measures
- Postoperative cognitive function [1 month 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.
- 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.
- 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)
- 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.
- 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
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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50 to 80 years old.
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ASA grade I-Ⅲ.
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elective knee or hip replacement.
Exclusion Criteria:
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Mini-Mental State Examination (MMSE) score < 23.
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Education years<7.
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Peptic ulcer disease, serious cardiac-cerebral vascular disease.
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Neurological or psychiatric disorders.
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History of drug and alcohol abuse.
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Hepatic and/or kidney dysfunction.
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BMI>35.
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Patients on antidepressants.
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ASA >Ⅲ.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xuzhou Central Hospital | Changzhou | Jiangsu | China | 221009 |
Sponsors and Collaborators
- Xuzhou Central Hospital
- The Affiliated Hospital of Xuzhou Medical University
- The First People's Hospital of Xuzhou
Investigators
- Principal Investigator: Yangzi Zhu, Doctor, Xuzhou Central Hospital
- Study Director: Liwei Wang, Doctor, Xuzhou Central Hospital
- Study Chair: Junli Cao, PhD & MD, Xuzhou Medical University
- Study Chair: Daqing Ma, PhD & MD, Imperial College London
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XuzhouCH20220620