The Effect of Intravenous Lidocaine on Postoperative Cognitive Function in Elderly Patients

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy of intravenous lidocaine on BDNF, NGF, miRNA-206 and miRNA-98 in serum in elderly patients undergoing abdominal surgery 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. Brain-derived neurotrophic factor (BDNF) and nerve growth factor (NGF), which are regulated by miRNA-206 and miRNA-98 respectively, play a key role in learning, memory, and cognition. Previous studies have shown that the levels of BDNF and NGF can be improved by lidocaine. The objective of this study is to investigate the efficacy of intravenous lidocaine on the incidence of early POCD, and the levels of BDNF, NGF, miRNA-206 and miRNA-98 in elderly patients undergoing abdominal surgery under general anesthesia.

Official Title
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Effects of Intravenous Lidocaine on Serum BDNF, NGF, miRNA-206 and miRNA-98 in Elderly Patients Undergoing Abdominal Surgery Under General Anesthesia

Conditions
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Organ Protection

Intervention / Treatment
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* Drug: Lidocaine
* Other: Normal saline (NS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients were scheduled by following abdominal surgery under general anesthesia Aged 65 - 80 years ASA physical status Ⅱ-Ⅲ Exclusion Criteria: Severe heart, pulmonary, hepatic and renal insufficiency History of neurological diseases (including Alzheimer's disease and stroke history) Psychological disorder, and drug or alcohol abuse History of anesthesia and surgery psychiatric illness Unwillingness to comply with the protocol or procedures Allergic to lidocaine Mini-Mental State Examination (MMSE) score<23 before surgery

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. | Other: Normal saline (NS)<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 BDNF at 1, 3 days after surgery | Venous blood samples were sampled before anaesthesia induction and 1, 3 days after surgery for the BDNF by using Enzyme-linked immunosorbent assay. | at preoperation,1 and 3 days postoperation | 
| Changes from Baseline NGF at 1, 3 days after surgery | Venous blood samples were sampled before anaesthesia induction and 1, 3 days after surgery for the NGF by using Enzyme-linked immunosorbent assay. | at preoperation,1 and 3 days postoperation | 
| Changes from Baseline miRNA-206 at 1, 3 days after surgery | Venous blood samples were sampled before anaesthesia induction and 1, 3 days after surgery for the miRNA-206 by using PCR. | at preoperation,1 and 3 days postoperation | 
| Changes from Baseline miRNA-98 at 1, 3 days after surgery | Venous blood samples were sampled before anaesthesia induction and 1, 3 days after surgery for the miRNA-98 by using PCR. | at preoperation,1 and 3 days postoperation | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative cognitive dysfunction, Lidocaine, Brain-derived neurotrophic factor, Nerve growth factor, miRNA-206, miRNA-98