NCT05503043

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

1.1 years

First QC Date

August 11, 2022

Last Update Submit

August 13, 2022

Conditions

Organ Protection

Keywords

lidocainepostoperative cognitive dysfunctionmiRNA-135aRock2Add1

Outcome Measures

Primary Outcomes (3)

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

    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

    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 Outcomes (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

Other Outcomes (1)

  • Postoperative cognitive dysfunction (POCD)

    at preoperation,1day and 3day after surgery

Study Arms (2)

Lidocaine

EXPERIMENTAL

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

Normal saline

PLACEBO COMPARATOR

Normal saline administered as a bolus and an infusion with identical volume and rate changes as the treatment group.

Drug: Normal saline

Interventions

LidocaineDRUG

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.

Lidocaine
Normal salineDRUG

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

Normal saline

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients undergoing elective non-cardiac surgery under general anesthesia
  • ASA physical status II-III
  • Aged ≥65 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postoperative Cognitive ComplicationsHereditary Sensory and Autonomic Neuropathies

Interventions

LidocaineSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental DisordersNervous System MalformationsNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Li Zhao

    General Hospital of Ningxia Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanxiang Ma

CONTACT

+86-13519591508mahanxiang@hotmail.com

Li Zhao

CONTACT

+86-15595293568zhaoli295@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2022

First Posted

August 16, 2022

Study Start

September 1, 2022

Primary Completion

September 30, 2023

Study Completion

December 30, 2023

Last Updated

August 16, 2022

Record last verified: 2022-08