CClinicalTrials.gg
Status unknownNCT05502705Updated Aug 16, 2022

The Effect of Intravenous Lidocaine on Postoperative Cognitive Function in Elderly Patients

An interventional study of Lidocaine and Normal saline (NS) in Organ Protection, sponsored by General Hospital of Ningxia Medical University. Status unknown. Open to participants aged 65 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-08-16.

Sponsored by General Hospital of Ningxia Medical University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
65 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

Brain-derived neurotrophic factor (BDNF) and nerve growth factor (NGF), which are regulated by miRNA-206 and miRNA-98 respectively, play a key role in learning, memory, and cognition. Previous studies have shown that the levels of BDNF and NGF can be improved by lidocaine.

The objective of this study is to investigate the efficacy of intravenous lidocaine on the incidence of early POCD, and the levels of BDNF, NGF, miRNA-206 and miRNA-98 in elderly patients undergoing abdominal surgery under general anesthesia.

02

Conditions studied

  • Organ Protection

Keywords

  • Postoperative cognitive dysfunction
  • Lidocaine
  • Brain-derived neurotrophic factor
  • Nerve growth factor
  • miRNA-206
  • miRNA-98
03

In context

Lead sponsor

General Hospital of Ningxia Medical University is the lead sponsor of 102 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
50 participants (estimated)

Study arms

  • 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

  • Placebo comparator
    Normal saline

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

    Other: Normal saline (NS)

Interventions

  • DrugLidocaine

    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

  • OtherNormal saline (NS)

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: at preoperation,1 and 3 days postoperation

  2. 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.

    Time frame: at preoperation,1 and 3 days postoperation

  3. 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.

    Time frame: at preoperation,1 and 3 days postoperation

  4. 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.

    Time frame: at preoperation,1 and 3 days postoperation

Secondary outcomes

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

    MMSE was performed

    Time frame: at preoperation,1 and 3 days postoperation

Other outcomes

  1. Postoperative cognitive dysfunction (POCD)

    the incidence of POCD

    Time frame: at preoperation,1 and 3 days postoperation

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05502705
Lead sponsor
General Hospital of Ningxia Medical University
Responsible party
Sponsor
First posted
Aug 16, 2022
Start date
Sep 1, 2022 (estimated)
Primary completion
Sep 1, 2024 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Aug 16, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion