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

Sponsor
General Hospital of Ningxia Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05503043
Collaborator
(none)
50
2
15.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
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.

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 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 miRNA-135a and Its Downstream Proteins Rock2 and Add1 in Elderly Patients Undergoing Non-cardiac Surgery Under General Anesthesia.
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

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.

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

Outcome Measures

Primary Outcome Measures

  1. Changes from Baseline miRNA-135A at the end of surgery immediately and 1, 3days after surgery [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

  2. Changes from Baseline Rock2 at the end of surgery immediately and 1, 3days after surgery [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

  3. Changes from Baseline Add1 at the end of surgery immediately and 1, 3days after surgery [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

Secondary Outcome Measures

  1. Changes from Baseline mini-mental state examination (MMSE) at the end of surgery immediately and 1, 3days after surgery [at preoperation,1day and 3day after surgery]

    MMSE was performed

Other Outcome Measures

  1. Postoperative cognitive dysfunction (POCD) [at preoperation,1day and 3day after surgery]

    the incidence of POCD

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • General Hospital of Ningxia Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
General Hospital of Ningxia Medical University
ClinicalTrials.gov Identifier:
NCT05503043
Other Study ID Numbers:
  • Li-Zhao
First Posted:
Aug 16, 2022
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by General Hospital of Ningxia Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2022