Carbohydrates and Proteins 3h Before Surgery
Condition: Surgery; Postoperative Complications; Inflammation
MeSH terms: Inflammation; Postoperative Complications
Study type: Interventional
Phase: Phase 3

Summary: 
      Prolonged pre-operative fasting increases postoperative hospital stay and current evidence
      recommends carbohydrate (CHO) drinks 2 hours before surgery. Our hypothesis is that the
      addition of hydrolized protein to a CHO-based drink not only reduces the inflammatory
      response but also diminish hospitalization.
    

Detailed description: 
      This was a randomized, double-blind, clinical study carried out at the Julio Muller
      University Hospital (Mato Grosso State, Brazil). The study was approved by the hospital
      Research Ethics Committee registered under number 723/CEP-HUJM/09 and is in accordance with
      the ethics principals set out in the Helsinki Declaration (2000), and meets Brazilian
      national legal specifications.

      Inclusion criteria includes adults (18-65 years-old), of both sexes, and candidates to
      elective major operations such as subtotal gastrectomy, colectomy, and anterior resection of
      the rectum for malignancies. Exclusion criteria were having diabetes mellitus, chronic kidney
      failure, chronic liver disease or serum bilirubin greater than 2 mg/dL, body mass index (BMI)
      above 35Kg/m2, American Anesthesiologists Association (ASA) score above 3, gastro-esophageal
      reflux, gastroparesis or intestinal obstruction. Patients with any non-compliance with the
      study protocol, or who had associated operations, or presented severe intraoperative
      complications (any type of shock, cardiac arrest, coagulations problems), or experienced
      prolonged operations (lasting more than 6 hours) were also excluded.

      Patient randomization was carried out on admission to the hospital using random numbers
      issued by a computer program (www.graphpad.com). For the randomization the precepts of the
      CONSORT flow diagram were followed.

      The patients were randomized into two groups: the study group and the control group. The
      patients were given a specific drink to their group on the evening prior to surgery and three
      hours before the operation. The study group received 400 ml (evening drink) or 200 ml (3h
      prior to operation drink) of a solution containing 11% de protein (pea hydrolized proptein),
      89% de carbohydrates (maltodextrin 79% and saccharose 21%) e 0% of lipids (Providextra,
      Fresenius Kabi, São Paulo, Brasil) and the control group received conventional 6-8h fast. All
      the patients fasted for solids at least 6 hours from the operation.

      On the day before the surgery and on the second postoperative day blood samples were
      collected for glucose, insulin, triglycerides, albumin, pre-albumin, CRP, and α-1-acid
      glycoprotein (α-1-GA) assays. The HOMA-IR (Homeostasis Model Assessment-Insulin Resistance)
      equation was used to assess insulin resistance according to the formula: HOMA-IR = insulin
      (µU/mL) x glycaemia (mg/dL) / 405. To assess inflammatory activity the PINI (CRP (mg/L) x
      α-1-GA (mg/L)/ albumin (g/L) x pre-albumin (mg/L) and the CRP/albumin ratio were used.

      The mean outcome variable was the length of postoperative stay. Other endpoints included the
      infectious morbidity, the insulin resistance assessed by HOMA-IR, and the inflammatory
      indexes or markers mentioned above.
    

Intervention name(s): Carbohydrate plus hydrolyzed protein beverage; Preoperative fasting of 8h
Intervention type(s): Dietary Supplement; Other
Intervention description(s): The study group received 400 ml (evening drink) or 200 ml (3h prior to operation drink) of a solution containing 11% de protein (pea hydrolized proptein), 89% de carbohydrates (maltodextrin 79% and saccharose 21%) e 0% of lipids (Providextra, Fresenius Kabi, São Paulo, Brasil). All the patients fasted for solids at least 6 hours from the operation; Conventional protocol of 8h fasting before an operation
Other intervention name(s): Providextra, Fresenius Kabi, São Paulo, Brasil; Control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Preoperative fasting; Acute phase proteins; Carbohydrates; Protein hydrolizate; Inflammatory response; Surgery