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

February 9, 2021 updated by: Alexandru Alexa, Iuliu Hatieganu University of Medicine and Pharmacy

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Romania
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400469
        • Recruiting
        • Institutu Regional de Gastroenterologie si Hepatologi Prof. Dr. O. Fodor
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sevoflurane
Patients will receive a general volatile anesthesia with Sevoflurane as anesthetic agent
Biological: Blood extraction
The patients will donate after consent 10 ml of blood prior and after surgery for further study
Other Names:
  • Biologic Human Blood
Drug: Sevoflurane
Patients will receive a general volatile anesthesia with Sevoflurane as anesthetic agent
Other Names:
  • Volatile Anesthetic Drug
Experimental: Total intravenous anesthesia
Patients will receive a general anesthesia with Propofol as anesthetic agent
Biological: Blood extraction
The patients will donate after consent 10 ml of blood prior and after surgery for further study
Other Names:
  • Biologic Human Blood
Drug: Propofol
Patients will receive a general anesthesia with Propofol as anesthetic agent
Other Names:
  • Intravenous Anesthetic Drug
Experimental: Total intravenous anesthesia and Lidocaine
Patients will receive a general anesthesia with Propofol as anesthetic agent and will also receive a fully lidocaine infusion according to the lidocaine protocol
Biological: Blood extraction
The patients will donate after consent 10 ml of blood prior and after surgery for further study
Other Names:
  • Biologic Human Blood
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
Other Names:
  • Antiarrythmic drug
No Intervention: Placebo
10 presumed healthy volunteers that have donated 10 ml of venous blood for serum comparison

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lidocaine concentration
Time Frame: 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
up to 4 years
Survival Comparison
Time Frame: 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.
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Investigators

  • Study Director: Ionescu Daniela, MD PHD DEEA, UMF Iuliu Hatieganu Cluj-Napoca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2018

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

October 13, 2019

First Submitted That Met QC Criteria

November 10, 2019

First Posted (Actual)

November 14, 2019

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 418/14.11.2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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