Residual Gastric Volume After the Ingestion of a Beverage Containing Carbohydrates Plus Whey Protein
Condition: Peptic Ulcer; Gastritis
MeSH terms: Gastritis; Peptic Ulcer
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Carbohydrate enriched-drinks has been used as preoperative treatment up to two hours before
      anesthesia. These drinks are safe and are not associated to bronchial aspiration during
      anesthesia. The addition of protein may be beneficial for metabolic preconditioning but there
      is a few data in literature testing these drinks for safety. The aim of the study will be to
      investigate the residual gastric volume (RGV) measured during the gastroscopy with
      abbreviation of fast to 2h with a carbohydrate plus whey protein enriched-drink.
    

Detailed description: 
      The use of carbohydrate-rich beverage in the immediate preoperative period is not only safe,
      but may also reduce the catabolic stress response, nausea, vomiting, and thus enhance
      postoperative recovery.The addition of protein may increase the benefits but there are few
      studies on this matter. Several studies have also shown the nutritional qualities of soluble
      whey proteins. Whey protein contains a high level of essential amino acids especially
      branched-chain amino acids. The digestibility and gastric emptying is accelerated when
      compared to casein. We thought that gastroscopy would be an excellent model to test the
      gastric emptying of such drinks before testing it for elective operations. Thus, the aim of
      the study will be to investigate the residual gastric volume (RGV) measured during the
      gastroscopy with abbreviation of fast to 2h with a carbohydrate- whey protein-drink.

      Methods A group of adult patients (age ranging from 18 to 72years-old) scheduled to
      undergoing upper digestive endoscopy for diagnostic purposes due to epigastric burning at
      Gastroclinica, Cuiabá, Brazil will be eligible for inclusion in this trial. Exclusion
      criteria will be: American Society of Anesthesiologists (ASA) score above II, diabetes
      mellitus, pregnancy, renal or hepatic failure, gastroesophageal reflux, morbid obesity (BMI
      above 40 kg/m2,acute cholecystitis, use of corticosteroids up to 6 months previously, use of
      any prokinetic drug up to 6 weeks, and any noncompliance or violation on the assigned
      protocol of preoperative fasting. The local ethics committee approved the study, and all
      patients will authorize his/her inclusion in the study by written informed consent.

      Randomization A staff not involved with the study will proceed with the randomization
      process. A computer program will generate random numbers to assign patients to the two
      groups. Patients will be randomized to receive either conventional preoperative fasting of 8
      hours (fasted group, n=15) or will receive instruction to 2 hours fast (study group, n=15).
      Patients belonging to study group will fast for solids for 8h and will drink 200mL of a
      beverage containing maltodextrine in addition to whey protein (Fresubin Jucy, Fresenius Kabi,
      Brazil) 2 hours before the initiation of sedation with propofol for the endoscopic exam.

      Fasting protocol All patients will receive both oral and written information about the
      protocol at the outpatient clinic. Endoscopies will be scheduled to begin at 8:00 AM. The
      evening before operation patients will be free to ingest solid food until 11:00 PM. The
      patients belonging to the abbreviation of fasting will receive written instructions to ingest
      the above beverage at 6:00 AM (200 mL), and be at the Gastroclinica unit at 7:00 AM.

      Endoscopy protocol Endoscopy will be performed by a certified gastroenterologist staff as
      routine. Special attention will be done for RGV. The finding of any residual gastric contents
      will mean that the content will be aspirate and measured. The RGV measured in mL will be the
      main outcome measure of the study.

      Outcome variable and statistical analysis The main endpoint of the study was the RGV.
      Comparison of RGV between the two groups will be done by either Student t test or
      Mann-Whitney test. A 5% will be established as significant level.
    

Intervention name(s): Carbohydrate plus whey protein enriched drink
Intervention type(s): Dietary Supplement
Intervention description(s): The patients will drink 200 mL of the nutritional supplement (Jucy, Fresenius Kabi, Brazil) 2h before upper digestive endoscopy under sedation with propofol.
Other intervention name(s): Jucy (Fresenius Kabi, Brazil); Study group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Keywords: gastric emptying; whey protein; carbohydrate; fasting