Diabetes Mellitus type 2
Conditions
Interventions
The control group (Group S) composed of 33 diabetic patients will receive Normal Saline Solution (0.9%) intravenously during the laparoscopic cholecystectomy procedure while the intervention group (Gr
Sponsors
Complexo Hospitalar Santa Genoveva
Uberlândia Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of Diabetes Mellitus; Physical status of the American Society of Anesthesiologist (ASA) II and III; male or female; aged between 18 and 65 years; undergoing elective videolaparoscopic cholecystectomy under general anesthesia
Exclusion criteria
Exclusion criteria: Patients with poorly controlled blood glucose levels (blood glucose higher than 250 mg/dL); impaired kidney or liver function; ischemic heart disease; ongoing infection; patients receiving corticosteroid therapy. Exclusion criteria after randomization will be: protocol violation; major surgical complication (hemorrhage, hollow visceral perforation); presence of ongoing cholecystitis; cardiovascular or respiratory adverse event requiring admission to the Intensive Care Unit; or patient request
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the present study is to evaluate the impact of crystalloid solutions on the plasma glucose level measured postoperatively, using the enzymatic colorimetric method (absorbance reading in a spectrophotometer), based on the finding of a variation of at least 30 mg /dL greater of pre- and post-intervention measurements in group R (Intervention Group) compared to group S (Control group). | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 01. Evaluate the impact of crystalloid solutions on the plasma lactate level measured postoperatively, using the enzymatic colorimetric method (absorbance reading in a spectrophotometer), based on the finding of a variation of at least 0.5 mmol/L greater in the measurements pre- and post-intervention in group R (Intervention Group) compared to group S (Control group).;Expected outcome 02. Evaluate the impact of crystalloid solutions on the plasma potassium level measured postoperatively, using the enzymatic method (kinetic mode), based on the finding of a variation of at least 0.5 mEq/L greater in the measurements pre- and post-intervention in group R (Intervention Group) compared to group S (Control group).;Expected outcome 03. Evaluate the impact of crystalloid solutions on the cumulative subcutaneous rescue regular insulin correction dose assessed postoperatively, using the patient's medical record during hospital stay, based on the finding of a variation of at least 5 IU (International Units) greater in the measurements pre- and post-intervention in group R (Intervention Group) compared to group S (Control group).;Expected outcome 04. Evaluate the impact of crystalloid solutions on the plasma bicarbonate level measured postoperatively, using the enzymatic method (kinetic mode), based on the finding of a variation of at least 2 mEq/L greater in the measurements pre- and post-intervention in group R (Intervention Group) compared to group S (Control group). | — |
Countries
Brazil
Contacts
Public ContactSecretaria Anestesiologia Santa Genoveva
Outcome results
None listed