Clinical trial NCT02114008: Residual Gastric Volume in Morbidly Obesa Diabetics. A Comparison of 3 Hour Versus Hour Fasting.
Official title: Residual Gastric Volume in Morbidly Obesa Diabetics. A Comparison of 3 Hour Versus Hour Fasting.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes
Fasting
Keywords: Gastric emptying.
Residual gastric volume.
Preoperative fasting.
Morbid Obesity.
Diabetes.
Lead sponsor: Cuiaba University
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria: patients between 18 and 55 years of age, of both sexes, with Body Index Mass (BMI) which is equal or greater than 40 Kg/m2, and type II diabetic that were using oral drugs or insulin to control the disease.

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Exclusion Criteria: patients who were using medications for gastrointestinal symptoms and/or who had prior abdominal operations.

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Primary outcomes:
measure: Residual gastric volume (RGV) in morbidly obese diabetics. A comparison of 3 hour versus 8 hour fasting
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cuiaba
country: Brazil
facility: Gunther Peres Pimenta
state: MT
Study officials:
affiliation: Cuiaba University
name: Gunther P Pimenta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: