NCT05502705

Brief Summary

The purpose of this study is to investigate the efficacy of intravenous lidocaine on BDNF, NGF, miRNA-206 and miRNA-98 in serum in elderly patients undergoing abdominal surgery 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

Typical duration for not_applicable

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

July 25, 2022

Completed
22 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
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

July 25, 2022

Last Update Submit

August 13, 2022

Conditions

Organ Protection

Keywords

Postoperative cognitive dysfunctionLidocaineBrain-derived neurotrophic factorNerve growth factormiRNA-206miRNA-98

Outcome Measures

Primary Outcomes (4)

  • Changes from Baseline BDNF at 1, 3 days after surgery

    Venous blood samples were sampled before anaesthesia induction and 1, 3 days after surgery for the BDNF by using Enzyme-linked immunosorbent assay.

    at preoperation,1 and 3 days postoperation

  • Changes from Baseline NGF at 1, 3 days after surgery

    Venous blood samples were sampled before anaesthesia induction and 1, 3 days after surgery for the NGF by using Enzyme-linked immunosorbent assay.

    at preoperation,1 and 3 days postoperation

  • Changes from Baseline miRNA-206 at 1, 3 days after surgery

    Venous blood samples were sampled before anaesthesia induction and 1, 3 days after surgery for the miRNA-206 by using PCR.

    at preoperation,1 and 3 days postoperation

  • Changes from Baseline miRNA-98 at 1, 3 days after surgery

    Venous blood samples were sampled before anaesthesia induction and 1, 3 days after surgery for the miRNA-98 by using PCR.

    at preoperation,1 and 3 days postoperation

Secondary Outcomes (1)

  • Changes from Baseline mini-mental state examination (MMSE) at 1, 3 days after surgery

    at preoperation,1 and 3 days postoperation

Other Outcomes (1)

  • Postoperative cognitive dysfunction (POCD)

    at preoperation,1 and 3 days postoperation

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.

Other: Normal saline (NS)

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 saline (NS)OTHER

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 were scheduled by following abdominal surgery under general anesthesia
  • Aged 65 - 80 years
  • ASA physical status Ⅱ-Ⅲ

You may not qualify if:

  • Severe heart, pulmonary, hepatic and renal insufficiency
  • History of neurological diseases (including Alzheimer's disease and stroke history)
  • Psychological disorder, and drug or alcohol abuse
  • History of anesthesia and surgery
  • psychiatric illness
  • Unwillingness to comply with the protocol or procedures
  • Allergic to lidocaine
  • Mini-Mental State Examination (MMSE) score\<23 before surgery

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 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

July 25, 2022

First Posted

August 16, 2022

Study Start

September 1, 2022

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

August 16, 2022

Record last verified: 2022-08