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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04162535
• Other study ID #: 418/14.11.2018
• Status: Recruiting
• Phase: Phase 1
• Start date: November 26, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2021
• Source: Iuliu Hatieganu University of Medicine and Pharmacy
• Contact: Alexandru Alexa, MD
• Phone: +40752691911
• Email: alexandru_reziati[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Lidocaine 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

Biological:
• Blood extraction
The patients will donate after consent 10 ml of blood prior and after surgery for further study

Drug:
• Sevoflurane
Patients will receive a general volatile anesthesia with Sevoflurane as anesthetic agent
• Propofol
Patients will receive a general anesthesia with Propofol as anesthetic agent

Locations

Country	Name	City	State
Romania	Institutu Regional de Gastroenterologie si Hepatologi Prof. Dr. O. Fodor	Cluj-Napoca	Cluj

Sponsors (3)

Lead Sponsor	Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy	Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor, Prof. Dr. I. Chiricuta Institute of Oncology

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Lidocaine concentration	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	up to 4 years
Secondary	Survival Comparison	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.	up to 5 years