Organ ProtectionNCT05502705
The Effect of Intravenous Lidocaine on Postoperative Cognitive Function in Elderly Patients
A study testing Lidocaine and Normal saline (NS) in people with Organ Protection, run by General Hospital of Ningxia Medical University.
Trial 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 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 (NS)
- 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 1 Dec 2024
- 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 were scheduled by following abdominal surgery under general anesthesia
- Aged 65 - 80 years
- ASA physical status Ⅱ-Ⅲ
Who cannot join
- 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
About this study
Official title: Effects of Intravenous Lidocaine on Serum BDNF, NGF, miRNA-206 and miRNA-98 in Elderly Patients Undergoing Abdominal Surgery Under General Anesthesia
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.
- Conditions
- Organ Protection
- Being tested
- Lidocaine, Normal saline (NS)
- Keywords
- Postoperative cognitive dysfunction, Lidocaine, Brain-derived neurotrophic factor, Nerve growth factor, miRNA-206, miRNA-98
- 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 saline (NS)Other
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: Other: Normal saline (NS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: at preoperation,1 and 3 days postoperation
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 completion1 Sep 2024 (estimated)
- Study completion1 Dec 2024 (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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502705
- Sponsor's protocol ID
- Yujingfang202201
- Status last verified
- Aug 2022
- First submitted
- 25 Jul 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 BDNF, NGF, miRNA-206 and miRNA-98 in Elderly Patients Undergoing Abdominal Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT05502705
- Acronym / sponsor ID
- Yujingfang202201
- Conditions
- Organ Protection
- Keywords
- Postoperative cognitive dysfunction, Lidocaine, Brain-derived neurotrophic factor, Nerve growth factor, miRNA-206, miRNA-98
- 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
- 1 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (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 efficacy of intravenous lidocaine on BDNF, NGF, miRNA-206 and miRNA-98 in serum in elderly patients undergoing abdominal surgery 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.
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.
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 | Other: Normal saline (NS)Normal 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 were scheduled by following abdominal surgery under general anesthesia
- Aged 65 - 80 years
- ASA physical status Ⅱ-Ⅲ
Key exclusion criteria (8 listed)
- 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
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 saline (NS)Patients are received equal volumes of saline intravenously until the end of the surgery | Other | Normal saline |
Primary outcome
Changes from Baseline BDNF at 1, 3 days after surgery
Time frame: at preoperation,1 and 3 days postoperation
Venous blood samples were sampled before anaesthesia induction and 1, 3 days after surgery for the BDNF by using Enzyme-linked immunosorbent assay.
Changes from Baseline NGF at 1, 3 days after surgery
Time frame: at preoperation,1 and 3 days postoperation
Venous blood samples were sampled before anaesthesia induction and 1, 3 days after surgery for the NGF by using Enzyme-linked immunosorbent assay.
Changes from Baseline miRNA-206 at 1, 3 days after surgery
Time frame: at preoperation,1 and 3 days postoperation
Venous blood samples were sampled before anaesthesia induction and 1, 3 days after surgery for the miRNA-206 by using PCR.
Changes from Baseline miRNA-98 at 1, 3 days after surgery
Time frame: at preoperation,1 and 3 days postoperation
Venous blood samples were sampled before anaesthesia induction and 1, 3 days after surgery for the miRNA-98 by using PCR.
1 secondary outcome
Changes from Baseline mini-mental state examination (MMSE) at 1, 3 days after surgery
Time frame: at preoperation,1 and 3 days postoperation
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
Related trials for Organ Protection
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
RecruitingPhase 3
Perioperative Argon Inhalation to Improve Neurocognitive Recovery After Carotid Surgery
Carotid Artery Disease, Carotid Artery Stenoses
RecruitingPhase 3
Nitric Oxide for Reduced Intensive Support in Cardiac Surgery With Cardiopulmonary Bypass
Nitric Oxide, Cardiac Surgery
Active, not recruiting
Impact of Diaphragmatic Breathing Coaching on Deep Inspiration Breath Hold Reproducibility and Organ Protection
Breathing, Mouth
Not yet recruitingPhase 2
Zoster Vaccine to Enhance Protection Against Zoster in Solid-organ Transplantation
Zoster; Herpes
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine and Normal saline (NS) 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 8 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline BDNF at 1, 3 days after surgery (time frame: at preoperation,1 and 3 days postoperation). The study lists 4 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.