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

NCT ID: NCT05502705

Last Updated: 2022-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-12-01

Brief Summary

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

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.

Conditions

Organ Protection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

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

Normal saline

Normal saline administered as a bolus and an infusion with identical volume and rate changes as the treatment group.

Group Type: PLACEBO_COMPARATOR

Normal saline (NS)

Intervention Type: OTHER

Patients are received equal volumes of saline intravenously until the end of the surgery

Interventions

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

Intervention Type: DRUG

Normal saline (NS)

Patients are received equal volumes of saline intravenously until the end of the surgery

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Ningxia Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Yujingfang202201

Identifier Type: -

Identifier Source: org_study_id