Obesity Clinical Trial
Official title:
Residual Gastric Volume in Morbidly Obesa Diabetics. A Comparison of 3 Hour Versus Hour Fasting.
To reduce the risk of aspiration for elective procedures, residual gastric volumes (RGV) have traditionally been minimized with overnight fasting. However, prolonged fasting can also have some adverse consequences and has been abandoned for some procedures in several patient populations with the exception of obese and/or diabetic patients. The aim of this study was to assess RGV in morbidly obese diabetic patients after traditional or abbreviated fasting.
Patients underwent two endoscopic examinations within two weeks. RGV was measured by
aspiration of gastric contentes into a graduated cylinder after traditional fasting (at
least 8 hours before the test) and after abbreviated fasting (3 hours with 200ml of water
containing 25g of 12.5% maltodextrin). All patients received both oral and written
information about the protocol at the outpatient clinic.
All the endoscopic procedures began at 9 AM, and were performed by the same board-certified
endoscopist, JMS, who was blinded as to the duration of the fast. The endoscopies were
conducted at Gastroclinica, Cuiaba, MT, in the period from April to June, 2013. Sedation was
performed by a board-certified anesthesiologist, who was also blinded as to the duration of
the fast. The anesthetic regimem included a intravenous bolus of 2 ml of lidocaine
hydrochloride (Astra Zeneca, São Paulo, Brazil) followed by 100 to 150mg of propofol before
endoscopy. Digital oximetry was monitored throughout the procedure. Patients were positioned
in the lateral recumbent position. A flexible electronic videoendoscope (EG2770K; Pentax
Corporation, Tokyo, Japan) of 9 mm in outer diameter was used. The main outcome variable was
the RGV measured by the endoscopist after aspiration of gastric residue.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
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