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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04162535

Enrollment

Registered

2019-11-14

Start date

2018-11-26

Completion date

2023-12-31

Last updated

2021-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Anesthesia, Propofol, Sevoflurane, Lidocaine, Cell Culture

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.

Interventions

DRUGLidocaine 1% Injectable Solution

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

BIOLOGICALBlood extraction

The patients will donate after consent 10 ml of blood prior and after surgery for further study

DRUGSevoflurane

Patients will receive a general volatile anesthesia with Sevoflurane as anesthetic agent

DRUGPropofol

Patients will receive a general anesthesia with Propofol as anesthetic agent

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* 18 to 80 years old patients admitted for elective colorectal surgery

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of the antiproliferative and apoptotic effects of anesthetic agents	up to 4 years	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.
Evaluation of patients serum on cell culture	up to 1 week	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.

Secondary

Measure	Time frame	Description
Lidocaine concentration	up to 4 years	The investigators aim to determine de plasmatic concentration of lidocaine in the patients serum , which have received lidocaine perioperatively. The investigators will do a Mass-Spec analysis of lidocaine
Survival Comparison	up to 5 years	The investigators will do a follow up for the patients in all the 3 groups. The investigators want to investigate the survival ratio for the patients that had a elective colorectal cancer surgery.

Countries

Romania

Contacts

Primary ContactAlexandru Alexa, MD

alexandru_reziati@yahoo.com+40752691911

Backup ContactIonescu Daniela, MD PHD

dionescuati@yahoo.com0744771209

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026