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
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
-
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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