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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Organ Protection
• Intervention / Treatment: Drug: Lidocaine; Other: Normal saline (NS)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine; 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; 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
Placebo Comparator: Normal saline; Normal saline administered as a bolus and an infusion with identical volume and rate changes as the treatment group.	Other: Normal saline (NS); Patients are received equal volumes of saline intravenously until the end of the surgery

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative cognitive dysfunction (POCD)	the incidence of POCD	at preoperation,1 and 3 days postoperation

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: August 13, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 13, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Postoperative cognitive dysfunction; Lidocaine; Brain-derived neurotrophic factor; Nerve growth factor; miRNA-206; miRNA-98
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: Yujingfang202201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No