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

NCT ID: NCT05503043

Last Updated: 2022-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-12-30

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.

Conditions

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Organ Protection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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

Intervention Type DRUG

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

Interventions

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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

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

Intervention Type DRUG

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
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Ningxia Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li Zhao

Role: PRINCIPAL_INVESTIGATOR

General Hospital of Ningxia Medical University

Central Contacts

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Hanxiang Ma

Role: CONTACT

+86-13519591508

Li Zhao

Role: CONTACT

+86-15595293568

Other Identifiers

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Li-Zhao

Identifier Type: -

Identifier Source: org_study_id

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