SurgeryPhase 4NCT03514550
Effects of Anesthesia on Immunity in Cancer
A Phase 4 study testing Propofol, Sevoflurane and Epidural block in people with Surgery and Renal Cancer, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
The aim of the study is a comparative study of the cellular immunity response of patients operated on for kidney cancer under total intravenous and inhalational anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Renal Cancer
- What is being tested?
- Propofol, Sevoflurane and Epidural block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteRussia
- Study dates
- 14 May 2018to 20 May 2019
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgery for renal cancer
- Signed informed concent
Who cannot join
- Propofol or sevoflurane intolerance
- Contraindications for epidural anesthesia
- Renal failure
- Hepatic failure
- Congestive heart failure
- Previous hemotherapy
- Hematological diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunomodulatory Effects of Volatile and Total Intravenous Anesthesia for Patients With Renal Cancer
The aim of the study is a comparative study of the cellular immunity response of patients operated on for kidney cancer under total intravenous and inhalational anesthesia.
Read the detailed description
The severity of perioperative immunosuppression is directly proportional to the degree of surgical stress. A series of experimental and clinical studies indicate a different effect of certain types of anesthesia on immunity. It is believed that surgical stress itself opens an opportunity for the recurrence of oncological diseases precisely due to the immunosuppressive effect. The aim of present pilot clinical study is to test a hypothesis that total intravenous anesthesia as superior to inhalational anesthesia in term of its effects on cell immunity among patients with kidney cancer.
- Conditions
- Surgery, Renal Cancer
- Being tested
- Propofol, Sevoflurane, Epidural block
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Propofol will be used for anesthesia during surgery
SevofluraneDrug
Sevoflurane will be used for anesthesia during surgery
Epidural blockProcedure or surgery
Epidural catheterization Th9-Th10, ropivacaine for perioperative analgesia
| Study group | Role | What they receive |
|---|---|---|
| total intravenous anesthesia | Experimental | Patients, scheduled for nephrectomy for kidney cancer will receive neuraxial epidural block and propofol for perioperative anesthesia Receives: Drug: Propofol; Procedure: Epidural block |
| Volatile anesthesia | Active comparator | Patients, scheduled for nephrectomy for kidney cancer will receive neuraxial epidural block and sevoflurane for perioperative anesthesia Receives: Drug: Sevoflurane; Procedure: Epidural block |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD 16
NK cells expression of CD16 receptor
Measured: postoperative day 1
Secondary outcomes (8)
CD45
CD45 expression on lymphocytes measured with flow cytometry
Measured: Baseline, end of surgery, postoperative days 1, 3-4, 7
CD3
CD3 expression on lymphocytes measured with flow cytometry
Measured: Baseline, end of surgery, postoperative days 1, 3-4, 7
CD19
CD19 expression on lymphocytes measured with flow cytometry
Measured: Baseline, end of surgery, postoperative days 1, 3-4, 7
CD4
CD4 expression on lymphocytes measured with flow cytometry
Measured: Baseline, end of surgery, postoperative days 1, 3-4, 7
CD8
CD8 expression on lymphocytes measured with flow cytometry
Measured: Baseline, end of surgery, postoperative days 1, 3-4, 7
CD16
CD16 expression on lymphocytes measured with flow cytometry
Measured: Baseline, end of surgery, postoperative days 1, 3-4, 7
CD25
CD25 expression on lymphocytes measured with flow cytometry
Measured: Baseline, end of surgery, postoperative days 1, 3-4, 7
HLA-DR
HLA-DR expression on lymphocytes measured with flow cytometry
Measured: Baseline, end of surgery, postoperative days 1, 3-4, 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start14 May 2018
- Primary completion1 Apr 2019
- Study completion20 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Efremov Sergey, Meshalkin Research Institute of Pathology of Circulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514550
- Sponsor's protocol ID
- Onko1
- Status last verified
- May 2019
- First submitted
- 13 Apr 2018
- Last updated
- 3 Jun 2019
- 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 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulatory Effects of Volatile and Total Intravenous Anesthesia for Patients With Renal Cancer
- ClinicalTrials.gov ID
- NCT03514550
- Acronym / sponsor ID
- Onko1
- Conditions
- Surgery, Renal Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 14 May 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 20 May 2019 (actual)
- First posted
- 2 May 2018 (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 aim of the study is a comparative study of the cellular immunity response of patients operated on for kidney cancer under total intravenous and inhalational anesthesia.
Detailed description
The severity of perioperative immunosuppression is directly proportional to the degree of surgical stress. A series of experimental and clinical studies indicate a different effect of certain types of anesthesia on immunity. It is believed that surgical stress itself opens an opportunity for the recurrence of oncological diseases precisely due to the immunosuppressive effect. The aim of present pilot clinical study is to test a hypothesis that total intravenous anesthesia as superior to inhalational anesthesia in term of its effects on cell immunity among patients with kidney cancer.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| total intravenous anesthesia | Experimental | Drug: Propofol, Procedure: Epidural blockPatients, scheduled for nephrectomy for kidney cancer will receive neuraxial epidural block and propofol for perioperative anesthesia |
| Volatile anesthesia | Active comparator | Drug: Sevoflurane, Procedure: Epidural blockPatients, scheduled for nephrectomy for kidney cancer will receive neuraxial epidural block and sevoflurane for perioperative anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Surgery for renal cancer
- Signed informed concent
Key exclusion criteria (7 listed)
- Propofol or sevoflurane intolerance
- Contraindications for epidural anesthesia
- Renal failure
- Hepatic failure
- Congestive heart failure
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 |
|---|---|---|
| PropofolPropofol will be used for anesthesia during surgery | Drug | total intravenous anesthesia |
| SevofluraneSevoflurane will be used for anesthesia during surgery | Drug | Volatile anesthesia |
| Epidural blockEpidural catheterization Th9-Th10, ropivacaine for perioperative analgesia | Procedure or surgery | Volatile anesthesia, total intravenous anesthesia |
Primary outcome
CD 16
Time frame: postoperative day 1
NK cells expression of CD16 receptor
8 secondary outcomes
CD45
Time frame: Baseline, end of surgery, postoperative days 1, 3-4, 7
CD3
Time frame: Baseline, end of surgery, postoperative days 1, 3-4, 7
CD19
Time frame: Baseline, end of surgery, postoperative days 1, 3-4, 7
CD4
Time frame: Baseline, end of surgery, postoperative days 1, 3-4, 7
CD8
Time frame: Baseline, end of surgery, postoperative days 1, 3-4, 7
CD16
Time frame: Baseline, end of surgery, postoperative days 1, 3-4, 7
CD25
Time frame: Baseline, end of surgery, postoperative days 1, 3-4, 7
HLA-DR
Time frame: Baseline, end of surgery, postoperative days 1, 3-4, 7
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 3 Jun 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol, Sevoflurane and Epidural block in people with Surgery and Renal Cancer, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 2 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: finished, as of the sponsor's last update on 3 Jun 2019. 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 Russia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
CD 16 (time frame: postoperative day 1). 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 3 Jun 2019; AzTrials last refreshed its copy on 7 Nov 2026.