Elucidation of the Mechanisms and Effects of Certain Anesthetic Interventions on Digestive Cancer Patients Subjected to Surgery
Contributions to the Elucidation of the Mechanisms and Effects by Which Certain Perianesthetic Interventions Modify Long-term Evolution of Patients With Digestive Cancers Subjected to Surgery
1 other identifier
interventional
40
1 country
1
Brief Summary
Digestive cancers (liver, colonic, pancreatic) have a high incidence and high mortality, their population prevalence is also increasing. Given that the anesthesia techniques and the agents used act directly and indirectly on the immune system during the perioperative period, influencing both the treatment and the prognosis of patients with colorectal cancer who undergo elective interventions, a series of perianesthetic interventions have been proposed in order to reduce morbidity-mortality perioperative.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 colorectal-cancer
Started Nov 2018
Longer than P75 for phase_1 colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 26, 2018
CompletedFirst Submitted
Initial submission to the registry
October 13, 2019
CompletedFirst Posted
Study publicly available on registry
November 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedFebruary 10, 2021
February 1, 2021
5.1 years
October 13, 2019
February 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Evaluation of the antiproliferative and apoptotic effects of anesthetic agents
The investigators aim to correlate the anticancer effects of two anesthetic techniques with tumor markers (p53;p38) and cell proteins involved in proliferation or apoptosis (IGFR;Bcl-2;Bcl-6). The investigators will report if the anesthetic agent used in cancer surgery influences the serologic values of these markers.
up to 4 years
Evaluation of patients serum on cell culture
The investigators will investigate the serum of the patients who received different types of anesthesia (elective colorectal cancer surgery) by incubating it with colon cell lines (HCT116). The investigators will concentrate on cell proliferation assay. The investigators aim to discover how the growth of HCT116 will be influenced by patients' serum in terms of rate of proliferation. The measurements which will be used are Inhibitory Concentration (IC50) measured at 0 , 24 and 48 hours after incubation. The concentrations will be measured in mcg/ml.
up to 1 week
Secondary Outcomes (2)
Lidocaine concentration
up to 4 years
Survival Comparison
up to 5 years
Study Arms (4)
Sevoflurane
EXPERIMENTALPatients will receive a general volatile anesthesia with Sevoflurane as anesthetic agent
Total intravenous anesthesia
EXPERIMENTALPatients will receive a general anesthesia with Propofol as anesthetic agent
Total intravenous anesthesia and Lidocaine
EXPERIMENTALPatients will receive a general anesthesia with Propofol as anesthetic agent and will also receive a fully lidocaine infusion according to the lidocaine protocol
Placebo
NO INTERVENTION10 presumed healthy volunteers that have donated 10 ml of venous blood for serum comparison
Interventions
Lidocaine 1% Injectable Solution Intervention Protocol for the TIVA and Lidocaine Arm * Induction: 1.5 mg / kg i.v. bolus before induction (at the vein catch). * Maintaining anesthesia: continuous infusion with Lidocaine 2 mg / kg / h, up to a maximum of 200 mg / h during maintenance (after IOT until waking) * Infusion with 1% Lidocaine will be reduced to 1.0- 1.5 mg / kg / hour, max 100 mg / hour, for the first 48 hours postop
The patients will donate after consent 10 ml of blood prior and after surgery for further study
Patients will receive a general volatile anesthesia with Sevoflurane as anesthetic agent
Patients will receive a general anesthesia with Propofol as anesthetic agent
Eligibility Criteria
You may qualify if:
- to 80 years old patients admitted for elective colorectal surgery
You may not qualify if:
- Pre-existing chronic pain
- Chronic medication that may interfere with pain: antiepileptics, NSAIDs, corticosteroids
- Contraindications to any of the medications in the study
- Significant psychiatric disorders (Axis I disorder) (major depressive disorders, bipolar disorders, schizophrenia, etc.)
- Hepatic (ALT and / or AST\> 2 normal wave) or renal (serum creatinine\> 2 mg / dl)
- Convulsive conditions that require medication in the last 2 years
- Planned regional analgesia and / or anesthesia (spinal or epidural)
- Corticosteroid-dependent asthma
- Autoimmune disorders
- Antiarrhythmic drugs (verapamil, propafenone, amiodarone) that may interfere with the antiarrhythmic action of lidocaine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institutu Regional de Gastroenterologie si Hepatologi Prof. Dr. O. Fodor
Cluj-Napoca, Cluj, 400469, Romania
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ionescu Daniela, MD PHD DEEA
UMF Iuliu Hatieganu Cluj-Napoca
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 13, 2019
First Posted
November 14, 2019
Study Start
November 26, 2018
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
February 10, 2021
Record last verified: 2021-02