An interventional study of Conventional monitor and Echocardiography in Anesthesia, sponsored by Federal University of Juiz de Fora. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-04-06.
Sponsored by Federal University of Juiz de Fora · Not applicable, Interventional, and Diagnostic
The study is a clinical trial, prospective and randomized of 60 patients of both genders, aged between 18 and 80 years, underwent major abdominal surgery. This study aims to compare plasma lactate levels in patients underwent major abdominal surgery (colectomy, gastrectomy, esophagectomy, pancreatectomy, Wertheim Meigs, liver and spleen surgeries) monitored by echocardiography or by conventional techniques (mean arterial pressure , Central venous pressure).
The study is a clinical trial, prospective and randomized of 60 patients of both genders, aged between 18 and 80 years, underwent major abdominal surgery. This study aims to compare plasma lactate levels in patients underwent major abdominal surgery (colectomy, gastrectomy, esophagectomy, pancreatectomy, Wertheim Meigs, liver and spleen surgeries) monitored by echocardiography or by conventional techniques (mean arterial pressure , Central venous pressure).
The investigators expect to observe a decrease in plasma lactate levels in patients submitted to echocardiographic monitoring when compared to patients submitted to conventional monitoring. In this way, to demonstrate that the routine use of transthoracic echocardiography in patients submitted to large surgery improves the clinical outcomes of these patients and presents a lower hospital cost.
The surgical indication will obey the criteria of the Federal University of Juiz de Fora surgery service, after clinical examination and routine preoperative laboratory tests (complete blood count, complete coagulogram, plasma sodium, potassium Plasma urea and plasma creatinine, blood glucose and liver function test), resting electrocardiogram and chest X-ray. All patients who agree to participate in the study will sign an Informed Consent Term in the preanesthetic evaluation (Appendix 1).
Patients will be computer randomly form by the GraphPad Prisma® program into two groups with 30 patients:
Conventional Group, Transthoracic Echocardiogram Group, All survey data will be noted in the Protocol Data Sheet (Appendix 2). Patients will be anesthetized by the researcher Dr. Marcello Fonseca Salgado Filho, who will also be responsible for performing the intraoperative TTE examination.
Federal University of Juiz de Fora is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
ages between 18 and 80 years.
Exclusion Criteria:
Emergency surgeries
Patients will be monitoring with invasive blood pressure, central venus catheter, plasma lactate, urinary output, oximeter, capnography and electrocardiography Echocardiography group: Patients will be monitoring with echocardiography, invasive blood pressure, central venus catheter, plasma lactate, urinary output, oximeter, capnogrphy and electrocardiography
Device: Conventional monitor
Patients will be monitoring with echocardiography, invasive blood pressure, central venus catheter, plasma lactate, urinary output, oximeter, capnography and electrocardiography
Device: Echocardiography
Patients underwent non-cardiac surgery will be monitoring by regular monitors
Patients will be monitoring by regular monitors plus echocardiography
plasma lactate
The plasma lactate will be collected in the arterial line
Time frame: 10 minutes after intubation, before incision
plasma lactate
The plasma lactate will be collected in the arterial line
Time frame: 10 min after the end of the surgery
Assessment heart rate
Heart rate
Time frame: 10 minutes after intubation, before incision
Assessment heart rate
Heart rate
Time frame: 10 min after the end of the surgery
Assessment blood pressure
blood pressure
Time frame: 10 minutes after intubation, before incision
Assessment blood pressure
blood pressure
Time frame: 10 min after the end of the surgery
Assessment venus oximetry
venus oximetry
Time frame: 10 minutes after intubation, before incision
Assessment venus oximetry
venus oximetry
Time frame: 10 min after the end of the surgery
Assessment arterial PH
arterial PH
Time frame: 10 minutes after intubation, before incision
Assessment arterial PH
arterial PH
Time frame: 10 min after the end of the surgery
Assessment fluid infusion
fluid infusion
Time frame: 10 min after the end of the surgery
Infection
Assessment sepsis
Time frame: 30 days after surgery
Surgery complications
Assessment fistulae
Time frame: 30 days after surgery
Post-operative mortality
death after surgery
Time frame: 30 days after surgery
Plan to share: No
This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Federal University of Juiz de Fora