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

October 26, 2019 updated by: Dr.Draghiciu Elena, Iuliu Hatieganu University of Medicine and Pharmacy

The Impact of Intravenous Anaesthesia on Angiogenesis in Patients With Breast Cancer

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 .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will enroll patients with ages between 18 and 80 years old, diagnosed with breast cancer but without proof of disease dissemination on medical imaging. After obtaining an informed consent the patients will be computer randomized to 4 groups. Each group will benefit from a certain type of anesthesia. The first group will be assigned general anesthesia using Sevoflurane for maintenance of hypnosis, the second group will be assigned general anesthesia with Sevoflurane and a continuous infusion of lidocaine 1%. The thrid group will be assigned total intravenous anesthesia using propofol for maintenance of hypnosis and the fourth group will be assigned to total intravenous anesthesia with propofol and a continuous infusion of lidocaine 1%. Before the surgical procedure a blood sample will be drawn from each patient for the measurement of serum vascular endothelial growth factor A ( VEGF-A). All the patients will receive pre-medication a night before the intervention with low molecular weight heparin (LMWH) and midazolam 5mg the morning of the intervention. For the first two groups the anesthetic induction will be conducted using propofol 1,5-2 mg/kg, fentanyl 1-3 microg/kg, atracurium 0,5 mg/kg.For the maintenance of anesthesia Sevoflurane will be used at a alveolar concentration of 1-1,5 MAC, as to maintain a BIS between 45-55. Intraoperative anesthesia will be ensured by using fentanyl boluses of 100 microg and the muscular relaxation needed for mechanical ventilation will be maintained using boluses of 10 mg of atracurium. At the end of the surgery the neuromuscular blockade will be antagonized with neostigmine 0.05 mg/kg and atropine 0.2 mg/kg. For the second group at the induction of anesthesia the patient will be administered a bolus of lidocaine 1% of 1.5 mg/kg and a continuous infusion of lidocaine 1% 2 mg/kg/h will be associated throughout the procedure and 1mg/kg/h,24 h postoperative. The postoperative analgesia will be assured by administering acetaminophen 1 g each 8 h and tramadol 25-50 mg each 4-6 h as needed. For the third and fourth groups the induction of aneshesia will be made using propofol administered by target controlled infusion (TCI) technique with a target plasma concentration of 4 microg/ml . Throughout the intervention the plasma concentration of propofol will be adjusted with increments of 0.2 microg/ml as to maintain a BIS between 45-55. To attenuate the response to laryngoscopy the patient will receive a bolus of fentanyl 1-3 microg/ml. During the intervention fentanyl will be administered in boluses of 100microg as needed. Muscular relaxation necessary for intubation will be provided using atracurium 0.5 mg/kg at induction of anesthesia and 10 mg boluses during the surgery as needed. At the end of the surgery the neuromuscular blockade will be antagonized with neostigmine 0.05 mg/kg and atropine 0.2 mg/kg. For the fourth group at the induction of anesthesia the patient will be administered a bolus of lidocaine 1% of 1.5 mg/kg and a continuous infusion of lidocaine 1% 2 mg/kg/h will be associated throughout the procedure and 1mg/kg/h, 24 h postoperative.Postoperative analgesia will be assured by administering acetaminophen 1 g each 8 h and tramadol 25-50 mg each 4-6 h as needed. Throughout the surgical intervention the patients will be monitored accordingly to the American Society of Anesthesiologists (ASA) standards (electrocardiogram-ECG, heart rate- HR, peripheral capillary oxygen saturation- SpO2, non-invasive blood pressure- NIBP, capnography and for the 3rd and 4th groups the bispectral index - BIS will be monitored). In the postoperative period non-invasive blood pressure -NIBP, heart rate- HR,peripheral capillary oxygen saturation SpO2, intensity of pain at 24 and 48 h will be monitored.Vascular endothelial growth factor- VEGF levels will be monitored at 24 h postoperative using ELISA technique. Vascular endothelial growth factor receptors 1 and 2 (VEGFR1 and VEGFR2) will be determined using immunohistochemical staining.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

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

Study Locations

  • Romania
      • Cluj-Napoca, Romania, 400015
        • IOCN Prof Dr I chiricuta

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • diagnosis of breast cancer
  • ASA risk class I-III
  • no metastatic disease

Exclusion Criteria:

  • hepatic, pulmonary metastasis
  • type I and II diabetes
  • rheumatoid arthritis
  • osteoarthritis
  • ischemic cardiovascular disease (history of myocardial infarction, angina)
  • peripheral vascular disease
  • endometriosis
  • allergies to lidocaine, fentanyl, propofol, sevoflurane, atracurium, midazolam, acetaminophen, tramadol
  • neuropsychiatric disorders
  • incapacity of understanding the study
  • refusal of participation

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Sevoflurane
The patients enrolled in this arm will receive general anesthesia in which the hypnosis will be maintained with Sevoflurane. Postoperative analgesia will be assured by the administration of tramadol and acetaminophen.A 0.05 mg/kg dose of neostigmine will be administered to antagonize the neuromuscular block at the end of surgery.A 0.2 mg/kg dose of atropine will be administered at the end of surgery to attenuate the parasymatomimetic effects of neostigmine.The bispectral index- BIS will be monitored throughout the anesthesia
Drug: Sevoflurane
maintenance of hypnosis during anaesthesia with sevoflurane
Drug: Acetaminophen
administration of 1 g acetaminophen for postoperative analgesia
Other Names:
  • paracetamol
Drug: Tramadol
administration of tramadol for postoperative analgesia
Other Names:
  • Tramal
Drug: Neostigmine
A 0.05 mg/kg dose of neostigmine will be administered to antagonize the neuromuscular block at the end of surgery.
Other Names:
  • Prostigmin, vagostigmin
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
Other Names:
  • atropine sulfate
Device: BIS
For the groups receveing TIVA-TCI anesthesia the bispectral index will be monitored
Other Names:
  • bispectral index monitor
ACTIVE_COMPARATOR: Sevoflurane+Lidocaine
The patients enrolled in this group will receive general anesthesia in which the hypnosis will be maintained with Sevoflurane. At the induction of anesthesia the patients will receive a bolus of lidocaine 1% 1.5 mg/kg. A continuous infusion of lidocaine 1% of 2 mg/kg/h will be associated throughout the surgical procedure and 1mg/kg/h until 24 h postoperative. Postoperative analgesia will be assured by the administration of tramadol and acetaminophen.A 0.05 mg/kg dose of neostigmine will be administered to antagonize the neuromuscular block at the end of surgery. A 0.2 mg/kg dose of atropine will be administered at the end of surgery to attenuate the parasymatomimetic effects of neostigmine.The bispectral index- BIS will be monitored throughout the anesthesia
Drug: Sevoflurane
maintenance of hypnosis during anaesthesia with sevoflurane
Drug: Acetaminophen
administration of 1 g acetaminophen for postoperative analgesia
Other Names:
  • paracetamol
Drug: Tramadol
administration of tramadol for postoperative analgesia
Other Names:
  • Tramal
Drug: Neostigmine
A 0.05 mg/kg dose of neostigmine will be administered to antagonize the neuromuscular block at the end of surgery.
Other Names:
  • Prostigmin, vagostigmin
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
Other Names:
  • atropine sulfate
Device: BIS
For the groups receveing TIVA-TCI anesthesia the bispectral index will be monitored
Other Names:
  • bispectral index monitor
Drug: Lidocaine
Continuous infusion of lidocaine
Other Names:
  • lidocaine 1%, lignocaine
EXPERIMENTAL: TIVA-TCI
The patients enrolled in this group will receive total intravenous anesthesia with propofol using a target controlled infusion technique for the maintenance of hypnosis throughout the surgery. Postoperative analgesia will be assured by the administration of tramadol and acetaminophen.A 0.05 mg/kg dose of neostigmine will be administered to antagonize the neuromuscular block at the end of surgery.A 0.2 mg/kg dose of atropine will be administered at the end of surgery to attenuate the parasymatomimetic effects of neostigmine. The bispectral index- BIS will be monitored throughout the anesthesia.
Drug: Acetaminophen
administration of 1 g acetaminophen for postoperative analgesia
Other Names:
  • paracetamol
Drug: Tramadol
administration of tramadol for postoperative analgesia
Other Names:
  • Tramal
Drug: Neostigmine
A 0.05 mg/kg dose of neostigmine will be administered to antagonize the neuromuscular block at the end of surgery.
Other Names:
  • Prostigmin, vagostigmin
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
Other Names:
  • atropine sulfate
Device: BIS
For the groups receveing TIVA-TCI anesthesia the bispectral index will be monitored
Other Names:
  • bispectral index monitor
Drug: TIVA-TCI
maintenance of hypnosis during anaesthesia with sevoflurane
Other Names:
  • Diprivan
ACTIVE_COMPARATOR: TIVA-TCI+lidocaine
The patients enrolled in this group will receive total intravenous anesthesia with propofol using a target controlled infusion technique for the maintenance of hypnosis throughout the surgery. At the induction of anesthesia the patients will receive a bolus of lidocaine 1% 1.5 mg/kg. A continuous infusion of lidocaine 1% of 2 mg/kg/h will be associated throughout the surgical procedure and 1mg/kg/h until 24 h postoperative. Postoperative analgesia will be assured by the administration of tramadol and acetaminophen.A 0.05 mg/kg dose of neostigmine will be administered to antagonize the neuromuscular block at the end of surgery. A 0.2 mg/kg dose of atropine will be administered at the end of surgery to attenuate the parasymatomimetic effects of neostigmine.The bispectral index- BIS will be monitored throughout the anesthesia.
Drug: Acetaminophen
administration of 1 g acetaminophen for postoperative analgesia
Other Names:
  • paracetamol
Drug: Tramadol
administration of tramadol for postoperative analgesia
Other Names:
  • Tramal
Drug: Neostigmine
A 0.05 mg/kg dose of neostigmine will be administered to antagonize the neuromuscular block at the end of surgery.
Other Names:
  • Prostigmin, vagostigmin
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
Other Names:
  • atropine sulfate
Device: BIS
For the groups receveing TIVA-TCI anesthesia the bispectral index will be monitored
Other Names:
  • bispectral index monitor
Drug: Lidocaine
Continuous infusion of lidocaine
Other Names:
  • lidocaine 1%, lignocaine
Drug: TIVA-TCI
maintenance of hypnosis during anaesthesia with sevoflurane
Other Names:
  • Diprivan

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
serum concentration of vascular endothelial growth factor A (VEGF-A)
Time Frame: 1 year
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
pain score
Time Frame: 1 year
assesed using visual-analogue scale
1 year
survival of patients
Time Frame: up to 5 years
up to 5 years
Vascular endothelial growth factor receptor 1 and 2 (VEGFR1 and VEGFR2) density
Time Frame: at the end of the study
at the end of the study

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Iuliu Hatieganu University of Medicine and Pharmacy

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Prof. Dr. I. Chiricuta Institute of Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IuliuHatieganu Cluj-Napoca

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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