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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional monitor group | Active Comparator | 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 |
|
| Echocardiography group | Active Comparator | Patients will be monitoring with echocardiography, invasive blood pressure, central venus catheter, plasma lactate, urinary output, oximeter, capnography and electrocardiography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional monitor | Device | Patients underwent non-cardiac surgery will be monitoring by regular monitors |
|
| Measure | Description | Time Frame |
|---|---|---|
| plasma lactate | The plasma lactate will be collected in the arterial line | 10 minutes after intubation, before incision |
| plasma lactate | The plasma lactate will be collected in the arterial line | 10 min after the end of the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment heart rate | Heart rate | 10 minutes after intubation, before incision |
| Assessment heart rate | Heart rate | 10 min after the end of the surgery |
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Inclusion Criteria:
ages between 18 and 80 years.
Exclusion Criteria:
Emergency surgeries
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcello F Salgado Filho, PhD | Contact | +5532999858833 | mfonsecasalgado@hotmail.com | |
| Izabela P Silva, MsC | Contact | +5532991152615 | izabelapalitot@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Marcello F Salgado Filho, PhD | Federal University of Juiz de Fora | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| federal University of Juiz de Fora | Recruiting | Juiz de Fora | Minas Gerais | 36036-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20705785 | Result | Forget P, Lois F, de Kock M. Goal-directed fluid management based on the pulse oximeter-derived pleth variability index reduces lactate levels and improves fluid management. Anesth Analg. 2010 Oct;111(4):910-4. doi: 10.1213/ANE.0b013e3181eb624f. Epub 2010 Aug 12. | |
| 20530615 | Result | Lobo SM, Rezende E, Knibel MF, Silva NB, Paramo JA, Nacul FE, Mendes CL, Assuncao M, Costa RC, Grion CC, Pinto SF, Mello PM, Maia MO, Duarte PA, Gutierrez F, Silva JM Jr, Lopes MR, Cordeiro JA, Mellot C. Early determinants of death due to multiple organ failure after noncardiac surgery in high-risk patients. Anesth Analg. 2011 Apr;112(4):877-83. doi: 10.1213/ANE.0b013e3181e2bf8e. Epub 2010 Jun 8. |
| Label | URL |
|---|---|
| anesthesia and analgesia | View source |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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
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| Echocardiography | Device | Patients will be monitoring by regular monitors plus echocardiography |
|
| Assessment blood pressure | blood pressure | 10 minutes after intubation, before incision |
| Assessment blood pressure | blood pressure | 10 min after the end of the surgery |
| Assessment venus oximetry | venus oximetry | 10 minutes after intubation, before incision |
| Assessment venus oximetry | venus oximetry | 10 min after the end of the surgery |
| Assessment arterial PH | arterial PH | 10 minutes after intubation, before incision |
| Assessment arterial PH | arterial PH | 10 min after the end of the surgery |
| Assessment fluid infusion | fluid infusion | 10 min after the end of the surgery |
| Infection | Assessment sepsis | 30 days after surgery |
| Surgery complications | Assessment fistulae | 30 days after surgery |
| Post-operative mortality | death after surgery | 30 days after surgery |
| 23152223 | Result | Grocott MP, Dushianthan A, Hamilton MA, Mythen MG, Harrison D, Rowan K; Optimisation Systematic Review Steering Group. Perioperative increase in global blood flow to explicit defined goals and outcomes following surgery. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD004082. doi: 10.1002/14651858.CD004082.pub5. |
| cochrane | View source |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |