The Impact of Intravenous Anaesthesia on Angiogenesis in Patients With Breast Cancer (TIVA/TCI-BC)

NCT02839668 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-10-29

No results posted yet for this study

Summary

Because neoplastic disease is one of the leading causes of death worldwide and breast cancer is one of the most frequent neoplasia among women, the possibility of influencing the evolution of patients starting from the moment of surgical intervention using a perianesthesic intervention is a scientific topic of high interest. The study will compare two anesthetic techniques and their efficiency in lowering the factors that can favorize the dissemination of neoplasia and their role in the prevention of postoperative pain. The serum level of vascular endothelial growth factor A (VEGF-A) will be determined before and after the surgical intervention after using two different types of anesthesia (inhalational and intravenous), and the immunohistochemical expression of vascular endothelial growth factor receptors (VEGFR) will be determined on the excised tissue. For the two different types of anesthesia a continuous infusion of lidocaine 1% will be associated. The study will compare the short-term and long term-outcome of the patients assigned the two different types of anesthesia and their immediate postoperative evolution .

Conditions

Interventions

DRUG

Lidocaine

Continuous infusion of lidocaine

DRUG

Sevoflurane

maintenance of hypnosis during anaesthesia with sevoflurane

DRUG

TIVA-TCI

maintenance of hypnosis during anaesthesia with sevoflurane

DRUG

Acetaminophen

administration of 1 g acetaminophen for postoperative analgesia

DRUG

Tramadol

administration of tramadol for postoperative analgesia

DRUG

Neostigmine

A 0.05 mg/kg dose of neostigmine will be administered to antagonize the neuromuscular block at the end of surgery.

DRUG

Atropine

A 0.2 mg/kg dose of atropine will be administered at the end of surgery to attenuate the parasymatomimetic effects of neostigmine

DEVICE

BIS

For the groups receveing TIVA-TCI anesthesia the bispectral index will be monitored

Sponsors & Collaborators

  • Prof. Dr. I. Chiricuta Institute of Oncology

    collaborator OTHER
  • Iuliu Hatieganu University of Medicine and Pharmacy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • Romania

Study Locations

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Entities

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 NCT02839668 on ClinicalTrials.gov