Anesthesia
Conditions
Keywords
Echocardiography, anesthesia, general surgery
Brief summary
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).
Detailed description
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.
Interventions
DEVICEConventional monitor
Patients underwent non-cardiac surgery will be monitoring by regular monitors
DEVICEEchocardiography
Patients will be monitoring by regular monitors plus echocardiography
Sponsors
Federal University of Juiz de Fora
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
The study is a clinical trial, prospective and random type, in which 60 patients, of both genders, aged between 18 and 80 years, who will undergo major abdominal surgery, divided in two groups. Patients will be randomly divided into two groups with 35 patients: Conventional Group, Transthoracic Echocardiogram Group
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
ages between 18 and 80 years. * both genders * Large abdominal surgeries * Elective surgeries
Exclusion criteria
* Emergency surgeries * Surgeries of the abdominal aorta * Ejection fraction \<30% * Blood creatinine levels\> 2.0mg / dl * Glycemia\> 200 g / dl * Do not agree to participate in the study * Bowel obstruction * Sepsis * Bilirubin\> 300 g / dl * Alcoholism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| plasma lactate | 10 minutes after intubation, before incision | The plasma lactate will be collected in the arterial line |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment blood pressure | 10 minutes after intubation, before incision | blood pressure |
| Assessment venus oximetry | 10 minutes after intubation, before incision | venus oximetry |
| Assessment arterial PH | 10 minutes after intubation, before incision | arterial PH |
| Assessment heart rate | 10 minutes after intubation, before incision | Heart rate |
| Infection | 30 days after surgery | Assessment sepsis |
| Surgery complications | 30 days after surgery | Assessment fistulae |
| Post-operative mortality | 30 days after surgery | death after surgery |
| Assessment fluid infusion | 10 min after the end of the surgery | fluid infusion |
Countries
Brazil
Contacts
Primary ContactMarcello F Salgado Filho, PhD
Backup ContactIzabela P Silva, MsC
Outcome results
None listed