Colorectal TumorsNCT05484687
Effect of Intravenous Infusion of Lidocaine on Patients Undergoing Radical Resection of Colorectal Tumors
A study testing Administer 1.5 mg/kg intravenously to the patient before induction of anesthesia, and continue to infuse 1.5 mg/kg/h during the operation until the end of the operation in people with Colorectal Tumors and Lidocaine, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
Colorectal cancer (CRC) is one of the most common malignant tumors in the world. Surgical resection is the main treatment option for colorectal cancer patients. Surgery may enhance or accelerate tumor recurrence and metastasis. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Colorectal Tumors, Lidocaine
- What is being tested?
- Administer 1.5 mg/kg intravenously to the patient before induction of anesthesia, and continue to infuse 1.5 mg/kg/h during the operation until the end of the operation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2020to 30 Jan 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- colorectal tumor patients
Who cannot join
- Weight <45kg and >100kg
- Sensitivity or hypersensitivity to lidocaine
- Second or third degree heart block
- Severe heart failure (ejection fraction < 20%)
- History of active rhythm disorder
- Acute severe liver and kidney injury
- History of uncontrolled seizures
- History of acute porphyria.
Trial locations and contacts
1 site in 1 country.
About this study
Colorectal cancer (CRC) is one of the most common malignant tumors in the world. Surgical resection is the main treatment option for colorectal cancer patients. Surgery may enhance or accelerate tumor recurrence and metastasis. Multiple factors in the tumor microenvironment play important roles in tumor recurrence and metastasis, and modulating the tumor microenvironment can inhibit disease progression. Lidocaine has been found to inhibit tumor growth in animal experiments.
Read the detailed description
Lidocaine was applied in the operation of colorectal tumor patients, and the effect on the postoperative microenvironment and micrometastasis of the patients was observed by detecting the stress, immunity, vascular tumor regeneration, inflammation, etc. of the patients.
- Conditions
- Colorectal Tumors, Lidocaine
- Being tested
- Administer 1.5 mg/kg intravenously to the patient before induction of anesthesia, and continue to infuse 1.5 mg/kg/h during the operation until the end of the operation
- Keywords
- Radical resection of colorectal tumor, lidocaine, stress, immunity, vascular tumor regeneration, inflammation, micrometastasis
- Medical subject headings
- Colorectal Neoplasms, Inflammation, Neoplasm Micrometastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administer 1.5 mg/kg intravenously to the patient before induction of anesthesia, and continue to infuse 1.5 mg/kg/h during the operation until the end of the operationDrug
Also called same volume of saline
Administer 1.5 mg/kg lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine is used in radical resection of colorectal tumors. | Experimental | Administer 1.5 mg/kg intravenously to the patient before induction of anesthesia, and continue to infuse 1.5 mg/kg/h during the operation until the end of the operation Receives: Drug: Administer 1.5 mg/kg intravenously to the patient before induction of anesthesia, and continue to infuse 1.5 mg/kg/h during the operation until the end of the operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the concentration of tumor micrometastasis markers were determined by ELISA
the concentration of tumor micrometastasis markers such as CK20 was determined by ELISA
Measured: 3 days after surgery
Secondary outcomes (4)
the concentration of stress hormones were determined by ELISA
the concentration of EPI and NE were determined by ELISA
Measured: 3 days after surgery
the concentration of inflammatory factor were determined by ELISA
the concentration of IL-6,IL-8,TNF-α were determined by ELISA
Measured: 3 days after surgery
the concentration of angiogenesis factors were determined by ELISA
the concentration of VEGF was determined by ELISA
Measured: 3 days after surgery
the concentration of immune indexes were determined by ELISA
the concentration of B lymphocytes, T lymphocytes, NK cells, macrophages were determined by ELISA
Measured: 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start24 Mar 2020
- Primary completion30 Dec 2021
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal TumorsStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hongsheng chen, Principal investigator, Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484687
- Sponsor's protocol ID
- MA2021008
- Status last verified
- Jan 2022
- First submitted
- 27 Jul 2022
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Infusion of Lidocaine on Patients Undergoing Radical Resection of Colorectal Tumors
- ClinicalTrials.gov ID
- NCT05484687
- Acronym / sponsor ID
- MA2021008
- Conditions
- Colorectal Tumors, Lidocaine
- Keywords
- Radical resection of colorectal tumor, lidocaine, stress, immunity, vascular tumor regeneration, inflammation, micrometastasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 24 Mar 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 2 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.
Colorectal cancer (CRC) is one of the most common malignant tumors in the world. Surgical resection is the main treatment option for colorectal cancer patients. Surgery may enhance or accelerate tumor recurrence and metastasis. Multiple factors in the tumor microenvironment play important roles in tumor recurrence and metastasis, and modulating the tumor microenvironment can inhibit disease progression. Lidocaine has been found to inhibit tumor growth in animal experiments.
Detailed description
Lidocaine was applied in the operation of colorectal tumor patients, and the effect on the postoperative microenvironment and micrometastasis of the patients was observed by detecting the stress, immunity, vascular tumor regeneration, inflammation, etc. of the patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lidocaine is used in radical resection of colorectal tumors. | Experimental | Drug: Administer 1.5 mg/kg intravenously to the patient before induction of anesthesia, and continue to infuse 1.5 mg/kg/h during the operation until the end of the operationAdminister 1.5 mg/kg intravenously to the patient before induction of anesthesia, and continue to infuse 1.5 mg/kg/h during the operation until the end of the operation |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- colorectal tumor patients
Key exclusion criteria (8 listed)
- Weight <45kg and >100kg
- Sensitivity or hypersensitivity to lidocaine
- Second or third degree heart block
- Severe heart failure (ejection fraction < 20%)
- History of active rhythm disorder
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 |
|---|---|---|
| Administer 1.5 mg/kg intravenously to the patient before induction of anesthesia, and continue to infuse 1.5 mg/kg/h during the operation until the end of the operationAlso: same volume of salineAdminister 1.5 mg/kg lidocaine | Drug | Lidocaine is used in radical resection of colorectal tumors. |
Primary outcome
the concentration of tumor micrometastasis markers were determined by ELISA
Time frame: 3 days after surgery
the concentration of tumor micrometastasis markers such as CK20 was determined by ELISA
4 secondary outcomes
the concentration of stress hormones were determined by ELISA
Time frame: 3 days after surgery
the concentration of inflammatory factor were determined by ELISA
Time frame: 3 days after surgery
the concentration of angiogenesis factors were determined by ELISA
Time frame: 3 days after surgery
the concentration of immune indexes were determined by ELISA
Time frame: 3 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
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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.
hongsheng chen principal investigator
Chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administer 1.5 mg/kg intravenously to the patient before induction of anesthesia, and continue to infuse 1.5 mg/kg/h during the operation until the end of the operation in people with Colorectal Tumors and Lidocaine, run by Affiliated Hospital of Nantong University at 1 site in China.
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 1 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: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the concentration of tumor micrometastasis markers were determined by ELISA (time frame: 3 days after surgery). 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 2 Aug 2023.