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

G

General Hospital of Ningxia Medical University

Status

Not yet enrolling

Conditions

Organ Protection

Treatments

Drug: Lidocaine
Drug: Normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT05503043
Li-Zhao

Details and patient eligibility

About

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.

Full 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.

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.

Enrollment

50 estimated patients

Sex

All

Ages

65 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups, including a placebo group

Lidocaine
Experimental group
Description:
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.
Treatment:
Drug: Lidocaine
Normal saline
Placebo Comparator group
Description:
Normal saline administered as a bolus and an infusion with identical volume and rate changes as the treatment group.
Treatment:
Drug: Normal saline

Trial contacts and locations

0

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Central trial contact

Hanxiang Ma; Li Zhao

Data sourced from clinicaltrials.gov

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