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

Sponsor

General Hospital of Ningxia Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05502705

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Organ Protection	Drug: Lidocaine Other: Normal saline (NS)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Changes from Baseline BDNF at 1, 3 days after surgery [at preoperation,1 and 3 days postoperation]
Venous blood samples were sampled before anaesthesia induction and 1, 3 days after surgery for the BDNF by using Enzyme-linked immunosorbent assay.
Changes from Baseline NGF at 1, 3 days after surgery [at preoperation,1 and 3 days postoperation]
Venous blood samples were sampled before anaesthesia induction and 1, 3 days after surgery for the NGF by using Enzyme-linked immunosorbent assay.
Changes from Baseline miRNA-206 at 1, 3 days after surgery [at preoperation,1 and 3 days postoperation]
Venous blood samples were sampled before anaesthesia induction and 1, 3 days after surgery for the miRNA-206 by using PCR.
Changes from Baseline miRNA-98 at 1, 3 days after surgery [at preoperation,1 and 3 days postoperation]
Venous blood samples were sampled before anaesthesia induction and 1, 3 days after surgery for the miRNA-98 by using PCR.

Secondary Outcome Measures

Changes from Baseline mini-mental state examination (MMSE) at 1, 3 days after surgery [at preoperation,1 and 3 days postoperation]
MMSE was performed

Other Outcome Measures

Postoperative cognitive dysfunction (POCD) [at preoperation,1 and 3 days postoperation]
the incidence of POCD

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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