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

NCT04162535 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-02-10

No results posted yet for this study

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.

Conditions

Interventions

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

DRUG

Propofol

Patients will receive a general anesthesia with Propofol as anesthetic agent

Sponsors & Collaborators

  • Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

    collaborator OTHER

  • Prof. Dr. I. Chiricuta Institute of Oncology

    collaborator OTHER

  • Iuliu Hatieganu University of Medicine and Pharmacy

    lead OTHER

Principal Investigators

  • Ionescu Daniela, MD PHD DEEA · UMF Iuliu Hatieganu Cluj-Napoca

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-26
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Romania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04162535 on ClinicalTrials.gov