Residual Gastric Volume in Morbidly Obesa Diabetics. A Comparison of 3 Hour Versus Hour Fasting.

Not Applicable

Completed

• Conditions: Obesity; Fasting; Diabetes
• Interventions: Other: Endoscopic examinations

• Registration Number: NCT02114008
• Lead Sponsor: Cuiaba University

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.

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-04
• Study First Submitted: 2014-04-12
• Study First Submitted QC: 2014-04-14
• Last Update Submitted: 2014-04-14
• Study First Posted: 2014-04-15
• Last Update Posted: 2014-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Traditional fasting	Endoscopic examinations	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).
Abbreviated fasting	Endoscopic examinations	Patients underwent two endoscopic examinations within two weeks. RGV was measured by aspiration of gastric contentes into a graduated cylinder after traditional after abbreviated fasting (3 hours with 200ml of water containing 25g of 12.5% maltodextrin).

Primary Outcome Measures

Name	Time	Method
Residual gastric volume (RGV) in morbidly obese diabetics. A comparison of 3 hour versus 8 hour fasting	3 months	This was a prospective, randomized, double-blind, and cross-over design in 8 morbidly obese type II diabetics with informed consent. RGV was measured endoscopically after three and eight hour fasts.

Trial Locations

Locations (1)

Gunther Peres Pimenta; 🇧🇷 Cuiaba, MT, Brazil