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

Primary Purpose

Colorectal Cancer

Status

Recruiting

Phase

Phase 1

Locations

Romania

Study Type

Interventional

Intervention

Lidocaine 1% Injectable Solution

Blood extraction

Sevoflurane

Propofol

About this trial

This is an interventional basic science trial for Colorectal Cancer focused on measuring Anesthesia, Propofol, Sevoflurane, Lidocaine, Cell Culture

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Institutu Regional de Gastroenterologie si Hepatologi Prof. Dr. O. FodorRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

Sevoflurane

Total intravenous anesthesia

Total intravenous anesthesia and Lidocaine

Placebo

Arm Description

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

Patients will receive a general anesthesia with Propofol as anesthetic agent

Patients will receive a general anesthesia with Propofol as anesthetic agent and will also receive a fully lidocaine infusion according to the lidocaine protocol

10 presumed healthy volunteers that have donated 10 ml of venous blood for serum comparison

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT04162535

First Posted

October 13, 2019

Last Updated

February 9, 2021

Sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Collaborators

Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor, Prof. Dr. I. Chiricuta Institute of Oncology

1. Study Identification

Unique Protocol Identification Number

NCT04162535

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Recruiting

Study Start Date

November 26, 2018 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Collaborators

Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor, Prof. Dr. I. Chiricuta Institute of Oncology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

Anesthesia, Propofol, Sevoflurane, Lidocaine, Cell Culture

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sevoflurane

Arm Type

Experimental

Arm Description

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

Arm Title

Total intravenous anesthesia

Arm Type

Experimental

Arm Description

Patients will receive a general anesthesia with Propofol as anesthetic agent

Arm Title

Total intravenous anesthesia and Lidocaine

Arm Type

Experimental

Arm Description

Patients will receive a general anesthesia with Propofol as anesthetic agent and will also receive a fully lidocaine infusion according to the lidocaine protocol

Arm Title

Placebo

Arm Type

No Intervention

Arm Description

10 presumed healthy volunteers that have donated 10 ml of venous blood for serum comparison

Intervention Type

Drug

Intervention Name(s)

Lidocaine 1% Injectable Solution

Other Intervention Name(s)

Antiarrythmic drug

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Blood extraction

Other Intervention Name(s)

Biologic Human Blood

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sevoflurane

Other Intervention Name(s)

Volatile Anesthetic Drug

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Propofol

Other Intervention Name(s)

Intravenous Anesthetic Drug

Intervention Description

Patients will receive a general anesthesia with Propofol as anesthetic agent

Primary Outcome Measure Information:

Title

Evaluation of the antiproliferative and apoptotic effects of anesthetic agents

Description

Time Frame

up to 4 years

Title

Evaluation of patients serum on cell culture

Description

Time Frame

up to 1 week

Secondary Outcome Measure Information:

Title

Lidocaine concentration

Description

Time Frame

up to 4 years

Title

Survival Comparison

Description

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.

Time Frame

up to 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alexandru Alexa, MD

Phone

+40752691911

alexandru_reziati@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ionescu Daniela, MD PHD

Phone

0744771209

dionescuati@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ionescu Daniela, MD PHD DEEA

Organizational Affiliation

UMF Iuliu Hatieganu Cluj-Napoca

Official's Role

Study Director

Facility Information:

Facility Name

Institutu Regional de Gastroenterologie si Hepatologi Prof. Dr. O. Fodor

City

Cluj-Napoca

State/Province

Cluj

ZIP/Postal Code

400469

Country

Romania

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexandru Alexa

Phone

+40752691911

alexandru_reziati@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

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

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