Elucidation of the Mechanisms and Effects of Certain Anesthetic Interventions on Digestive Cancer Patients Subjected to Surgery

Phase 1

• Conditions: Colorectal Cancer
• Interventions: Biological: Blood extraction; Drug: Lidocaine 1% Injectable Solution; Drug: Propofol; Drug: Sevoflurane

• Registration Number: NCT04162535
• Lead Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-26
• Study First Submitted: 2019-10-13
• Study First Submitted QC: 2019-11-10
• Study First Posted: 2019-11-14
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sevoflurane	Blood extraction	Patients will receive a general volatile anesthesia with Sevoflurane as anesthetic agent
Total intravenous anesthesia	Blood extraction	Patients will receive a general anesthesia with Propofol as anesthetic agent
Total intravenous anesthesia and Lidocaine	Blood extraction	Patients will receive a general anesthesia with Propofol as anesthetic agent and will also receive a fully lidocaine infusion according to the lidocaine protocol
Total intravenous anesthesia and Lidocaine	Lidocaine 1% Injectable Solution	Patients will receive a general anesthesia with Propofol as anesthetic agent and will also receive a fully lidocaine infusion according to the lidocaine protocol
Total intravenous anesthesia	Propofol	Patients will receive a general anesthesia with Propofol as anesthetic agent
Sevoflurane	Sevoflurane	Patients will receive a general volatile anesthesia with Sevoflurane as anesthetic agent

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Institutu Regional de Gastroenterologie si Hepatologi Prof. Dr. O. Fodor; 🇷🇴 Cluj-Napoca, Cluj, Romania