Organ ProtectionNCT05503043
Effect of Intravenous Lidocaine on Serum miRNA-135a in Patients Undergoing Non-cardiac Surgery
A study testing Lidocaine and Normal saline in people with Organ Protection, run by General Hospital of Ningxia Medical University.
Trial 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 more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Organ Protection
- What is being tested?
- Lidocaine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients undergoing elective non-cardiac surgery under general anesthesia
- ASA physical status II-III
- Aged ≥65 years
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
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.
- Conditions
- Organ Protection
- Being tested
- Lidocaine, Normal saline
- Keywords
- lidocaine, postoperative cognitive dysfunction, miRNA-135a, Rock2, Add1
- Medical subject headings
- Postoperative Cognitive Complications, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Normal salineDrug
Patients are received equal volumes of saline intravenously until the end of the surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: at preoperation,1day and 3day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ ProtectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Zhao, Principal investigator, General Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503043
- Sponsor's protocol ID
- Li-Zhao
- Status last verified
- Aug 2022
- First submitted
- 11 Aug 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05503043
- Acronym / sponsor ID
- Li-Zhao
- Conditions
- Organ Protection
- Keywords
- lidocaine, postoperative cognitive dysfunction, miRNA-135a, Rock2, Add1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: LidocaineIntravenous 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. |
| Normal saline | Placebo comparator | Drug: Normal salineNormal saline administered as a bolus and an infusion with identical volume and rate changes as the treatment group. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients undergoing elective non-cardiac surgery under general anesthesia
- ASA physical status II-III
- Aged ≥65 years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineIntravenous 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. | Drug | Lidocaine |
| Normal salinePatients are received equal volumes of saline intravenously until the end of the surgery | Drug | Normal saline |
Primary outcome
Changes from Baseline miRNA-135A at the end of surgery immediately and 1, 3days after surgery
Time frame: 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
Changes from Baseline Rock2 at the end of surgery immediately and 1, 3days after surgery
Time frame: 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
Changes from Baseline Add1 at the end of surgery immediately and 1, 3days after surgery
Time frame: 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
1 secondary outcome
Changes from Baseline mini-mental state examination (MMSE) at the end of surgery immediately and 1, 3days after surgery
Time frame: at preoperation,1day and 3day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Zhao principal investigator
General Hospital of Ningxia Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine and Normal saline in people with Organ Protection, run by General Hospital of Ningxia Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanxiang Ma (+86-13519591508, mahanxiang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline miRNA-135A at the end of surgery immediately and 1, 3days after surgery (time frame: at preoperation, at the end of surgery immediately, 1day and 3day after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.