Effect of Intravenous Lidocaine on Serum miRNA-135a in Patients Undergoing Non-cardiac Surgery

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effects of intravenous lidocaine on serum miRNA-135a and its downstream proteins Rock2 and Add1 in elderly patients undergoing non-cardiac under general anesthesia.

Detailed Description
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Postoperative cognitive dysfunction (POCD) is a major complication following surgeries and anesthesia, especially in elderly individuals. Lidocaine, an inexpensive, widely available, and relatively safe compound, is a local anesthetic that readily crosses the blood-brain barrier. Intravenous lidocaine can reduce the incidence of POCD. However, the mechanism is still unclear. Rock2 and Add1, which are regulated by miRNA-135a, play a key role in learning, memory, and cognition. The objective of this study is to investigate the efficacy of intravenous lidocaine on the incidence of early POCD, and the levels of Rock2, Add1, and miRNA-135a in elderly patients undergoing non-cardiac under general anesthesia.

Official Title
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Effects of Intravenous Lidocaine on Serum miRNA-135a and Its Downstream Proteins Rock2 and Add1 in Elderly Patients Undergoing Non-cardiac Surgery Under General Anesthesia.

Conditions
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Organ Protection

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective non-cardiac surgery under general anesthesia ASA physical status II-III Aged ≥65 years Exclusion Criteria: Serious heart, lung, liver and kidney diseases Central nervous system injury Mental illness and drug dependence On regular use of analgesic/sedative/antidepressant Unable to cooperate Allergy to lidocaine MMSE < 23 points

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine<br>Intravenous bolus of 1.5 mg/kg of lidocaine followed by a continuous infusion of 3.0 mg/kg for the first hour, 1.5 mg/kg for the second hour, 0.7 mg/kg until the end of the surgery. | Drug: Lidocaine<br>* Intravenous bolus of 1.5 mg/kg of lidocaine followed by a continuous infusion of 3.0 mg/kg for the frst hour, 1.5 mg/kg for the second hour, 0.7 mg/kg until the end of the surgery.<br>|
| Placebo Comparator: Normal saline<br>Normal saline administered as a bolus and an infusion with identical volume and rate changes as the treatment group. | Drug: Normal saline<br>* Patients are received equal volumes of saline intravenously until the end of the surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Baseline miRNA-135A at the end of surgery immediately and 1, 3days after surgery | Venous blood was extracted, and the serum miRNA-135a level of patients were detected by PCR and ELISA before surgery, at the end of surgery, 1day and 3day after surgery | at preoperation, at the end of surgery immediately, 1day and 3day after surgery | 
| Changes from Baseline Rock2 at the end of surgery immediately and 1, 3days after surgery | Venous blood was extracted, and the serum Rock2 level of patients were detected by PCR and ELISA before surgery, at the end of surgery, 1day and 3day after surgery | at preoperation, at the end of surgery immediately, 1day and 3day after surgery | 
| Changes from Baseline Add1 at the end of surgery immediately and 1, 3days after surgery | Venous blood was extracted, and the serum Add1 level of patients were detected by PCR and ELISA before surgery, at the end of surgery, 1day and 3day after surgery | at preoperation, at the end of surgery immediately, 1day and 3day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Baseline mini-mental state examination (MMSE) at the end of surgery immediately and 1, 3days after surgery | MMSE was performed | at preoperation,1day and 3day after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lidocaine, postoperative cognitive dysfunction, miRNA-135a, Rock2, Add1