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

August 13, 2022 updated by: General Hospital of Ningxia Medical University

Effects of Intravenous Lidocaine on Serum miRNA-135a and Its Downstream Proteins Rock2 and Add1 in Elderly Patients Undergoing Non-cardiac Surgery Under General Anesthesia.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Drug: Normal saline
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 miRNA-135A at the end of surgery immediately and 1, 3days after surgery
Time Frame: at preoperation, at the end of surgery immediately, 1day and 3day after surgery
Venous blood was extracted, and the serum miRNA-135a level of patients were detected by PCR and ELISA before surgery, at the end of surgery, 1day and 3day after surgery
at preoperation, at the end of surgery immediately, 1day and 3day after surgery
Changes from Baseline Rock2 at the end of surgery immediately and 1, 3days after surgery
Time Frame: at preoperation, at the end of surgery immediately, 1day and 3day after surgery
Venous blood was extracted, and the serum Rock2 level of patients were detected by PCR and ELISA before surgery, at the end of surgery, 1day and 3day after surgery
at preoperation, at the end of surgery immediately, 1day and 3day after surgery
Changes from Baseline Add1 at the end of surgery immediately and 1, 3days after surgery
Time Frame: at preoperation, at the end of surgery immediately, 1day and 3day after surgery
Venous blood was extracted, and the serum Add1 level of patients were detected by PCR and ELISA before surgery, at the end of surgery, 1day and 3day after surgery
at preoperation, at the end of surgery immediately, 1day and 3day after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from Baseline mini-mental state examination (MMSE) at the end of surgery immediately and 1, 3days after surgery
Time Frame: at preoperation,1day and 3day after surgery
MMSE was performed
at preoperation,1day and 3day after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative cognitive dysfunction (POCD)
Time Frame: at preoperation,1day and 3day after surgery
the incidence of POCD
at preoperation,1day and 3day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Ningxia Medical University

Investigators

  • Principal Investigator: Li Zhao, General Hospital of Ningxia Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

August 11, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Li-Zhao

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Organ Protection

Clinical Trials on Lidocaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe