ClinicalTrials.gg
Status unknownNCT05503043Updated Aug 16, 2022

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

An interventional study of Lidocaine and Normal saline 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verified this record recently (last verified Aug 2022), so the status shown — last known as Not yet recruiting — may be out of date.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 effects of intravenous lidocaine on serum miRNA-135a and its downstream proteins Rock2 and Add1 in elderly patients undergoing non-cardiac 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.

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.

02

Conditions studied

  • Organ Protection

Keywords

  • lidocaine
  • postoperative cognitive dysfunction
  • miRNA-135a
  • Rock2
  • Add1
03

In context

Postoperative Cognitive Complications

269 studies on the registry are indexed under Postoperative Cognitive Complications; 56 are open to participants now.

This study's planned enrollment of 50 is below the median of 110 across 150 interventional studies indexed under Postoperative Cognitive Complications.

Browse Postoperative Cognitive Complications studies →

Lead sponsor

General Hospital of Ningxia Medical University is the lead sponsor of 106 studies on the registry; 40 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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.

    Drug: Normal saline

Interventions

  • 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.

  • DrugNormal saline

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: at preoperation, at the end of surgery immediately, 1day and 3day after surgery

  2. 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

    Time frame: at preoperation, at the end of surgery immediately, 1day and 3day after surgery

  3. 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

    Time frame: 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

    MMSE was performed

    Time frame: at preoperation,1day and 3day after surgery

Other outcomes

  1. Postoperative cognitive dysfunction (POCD)

    the incidence of POCD

    Time frame: at preoperation,1day and 3day after surgery

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

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2022; primary completion for Sep 2023, 12 months later.

Of 59 non-industry interventional studies with no phase under Postoperative Cognitive Complications, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 33. This study's planned 12 months is below that.

Counting every sponsor, half of 59 studies reached it within 15 months; a quarter within 8 and three quarters within 33.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2022
First posted
Aug 16, 2022
StartEst.
Sep 1, 2022
Primary completionEst.
Sep 30, 2023
CompletionEst.
Dec 30, 2023
Last update
Aug 16, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
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
NCT05503043
Responsible party
Sponsor
First posted
Aug 16, 2022
Start date
Sep 1, 2022 (estimated)
Primary completion
Sep 30, 2023 (estimated)
Completion
Dec 30, 2023 (estimated)
Last update
Aug 16, 2022

Study contacts

Hanxiang Ma
Contact
mahanxiang@hotmail.com
+86-13519591508
Li Zhao
Contact
zhaoli295@163.com
+86-15595293568
Li Zhao
principal investigator · General Hospital of Ningxia Medical University

Oversight

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

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Studies of the drug tested here: Lidocaine

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