Digestive system diseases, Digestive System Surgical Procedures, Elective Surgical Procedures, Anesthesia, General, Postoperative Complications.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: ASA I, II or III patients; Adults; Both sexes; Undergoing open abdominal surgeries; Minimum surgical duration of 120 minutes; Supine position during surgery; Undergoing general anesthesia
Exclusion criteria
Exclusion criteria: BMI greater than 35kg.m2; Gestation, chronic obstructive pulmonary disease or bronchial infection; Coagulopathies; Changes in preoperative renal function; Sepsis or SIRS; Hepatic insufficiency; Emergency or emergency surgeries; Refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1 Reduced hospital stay in days, from immediate postoperative to hospital discharge or death during hospitalization;Outcome found 1 There was no statistically significant difference between the control and bolus duration of hospitalization (p = 0.58);Expected outcome 2 Lower mortality in the first 30 days after surgery;Observed outcome 2 There was no statistically significant difference between the control and bolus groups regarding mortality in the first thirty days after surgery (p = 0.43);Expected outcome 3 Less time in days for the return of gastrointestinal tract function evaluated by first postoperative evacuation and reintroduction of diet.;Observed outcome 3 There was no statistically significant difference between the control and bolus groups regarding the return of gastrointestinal tract function, assessed by first postoperative evacuation (p = 0.95) and diet reintroduction (p = 0.22);Expected outcome 4 Reduced incidence of postoperative complications in the bolus group measured by the number of patients who presented at least 1 of the following postoperative complications (pneumonia, unprogrammed orotracheal intubation, surgical wound infection, wall dehiscence, anastomosis dehiscence, deep venous thrombosis, pulmonary thromboembolism, cardiac arrhythmia, acute renal injury, need for dialysis, sepsis / septic shock, hemorrhage, death for up to thirty days);Observed outcome 4 Reduced incidence of postoperative complications in the bolus group (14%) than in the control group (45%), p = 0.003. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint observed 2 Fewer postoperative pulmonary complications in the bolus group, being determined by the presence of pneumonia, unprogrammed orotracheal intubation, pulmonary thromboembolism and acute respiratory failure (p = 0.003).;Expected secondary endpoint 1 Reduced incidence of acute postoperative renal injury in the bolus group, as measured by serum creatinine, Ngal, and cystatin C levels measured on the preoperative, second and fifth postoperative days operative.;Expected secondary outcome 2 Fewer postoperative pulmonary complications in the bolus group, being determined by the presence of pneumonia, unprogrammed orotracheal intubation, pulmonary thromboembolism and acute respiratory failure.;Secondary outcome observed 1 There was no statistically significant difference between the control group and the bolus group for serum creatinine (p = 0.95), Ngal (p = 0.29), and Cystatin C (p = 0.86 ). | — |
Countries
Brazil
Contacts
Faculdade de Medicina de Botucatu UNESP