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Safety of Gastric Volume Emptying After the Intake of Maltodextrin and Glutamine

Primary Purpose

Pulmonary Aspiration of Gastric Contents, Adverse Effects in the Therapeutic Use of Other and Unspecified General Anaesthetics, Pulmonary Aspiration During Anaesthetic Induction

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Maltodextrin
Glutamine
Sponsored by
Federal University of Mato Grosso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Aspiration of Gastric Contents focused on measuring preoperative care, maltodextrine, glutamine, gastric residual volume, MRI

Eligibility Criteria

21 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Young male volunteers (aged between 21 and 30 years-old) with body mass index (BMI) between 20 and 29 kg/m2 and without either acute or chronic illness in the last 3 months.

Exclusion Criteria:

  • non-adherence to any phase of the study protocol,
  • gastroesophageal reflux disease,
  • previous history of intolerance to lactose,
  • gastroparesis or history of poor gastric emptying,
  • diabetes mellitus, and
  • previous abdominal surgery

Sites / Locations

  • Hospital Santa Rosa

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Maltodextrin

Glutamine

Arm Description

The volunteers ingested 400ml (4 hours before the exam was carried out) at 8:00AM and 200ml (2 hours before the exam was carried out) at 10:00AM of a beverage containing water plus 12.5% maltodextrin

The same volunteers ingested 400ml (4 hours before the exam was carried out) at 8:00AM and 200ml (2 hours before the exam was carried out) at 10:00AM of a beverage containing water plus 12.5% maltodextrin plus 15g of glutamine

Outcomes

Primary Outcome Measures

Gastric residual volume (GVR) ("change" is being assessed)
We measured the GRV by MRI immediately after ingestion (T0)and the changes of GVR after 120 (T120)and 180 minutes (T180)- "change" is being assessed

Secondary Outcome Measures

Vomiting
We observed whether the volunteer presented vomiting during the experiment

Full Information

First Posted
February 19, 2013
Last Updated
February 22, 2013
Sponsor
Federal University of Mato Grosso
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1. Study Identification

Unique Protocol Identification Number
NCT01798342
Brief Title
Safety of Gastric Volume Emptying After the Intake of Maltodextrin and Glutamine
Official Title
Gastric Residual Volume After He Intake Of Maltodextrin And Glutamine. A Randomized Double-Blind, Crossover Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Mato Grosso

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Carbohydrates (CHO)-based drinks 2h before the induction of anesthesia are recommended to decrease insulin resistance. The addition of glutamine (GLN) in these beverages may enhance the benefits of CHO alone. However, only a few studies tested the safety of this formula. The objective of this study was to evaluate the gastric residual volume (GRV) after the intake of a beverage containing CHO plus GLN using magnetic resonance (MRI).
Detailed Description
We included 11 male young volunteers (aged between 21 and 30 years-old) with body mass index (BMI) between 20 and 29 kg/m2 and without either acute or chronic illness in the last 3 months. The criteria for exclusion were non-adherence to any phase of the study protocol, gastroesophageal reflux disease, previous history of intolerance to lactose, gastroparesis or history of poor gastric emptying, diabetes mellitus, and previous abdominal surgery. Each volunteer was randomized for participation in the study in a blind fashion. All subjects underwent two different protocols before MRI with an interval of seven days between them. Both phases took place after an overnight fast of eight hours. The volunteers ingested 400ml (4 hours before the exam was carried out) at 8:00AM and 200ml (2 hours before the exam was carried out) at 10:00AM of a beverage containing either water plus 12.5% maltodextrin (Phloraceae, Cuiabá, Brazil; CHO group) or the same beverage plus 15g of GLN (Phloraceae, Cuiabá, Brazil; GLN group). The participants were instructed not to ingest alcohol, medication, and caffeine within 24 hours of the study, nor do any vigorous physical activity during that time. In both phases the individuals were blind to the specific drink and they were told to ingest the beverage in a maximum period of five minutes and T0 was defined as the moment they complete the intake of the solution.The powdered products (maltodextrin alone or maltodextrine plus glutamine) were packed in coded opaque sachets and the content was only known by the pharmacist who manipulated it. All the participants in the study underwent magnetic resonance of the upper abdomen at 12:00AM and 01:00PM. The GRV observed during the first exam was defined as T120 and the second exam as T180. All exams were performed by the same magnetic resonance equipment (Intera 1.5T ; Philips Healthcare, Eindhoven, Holland).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Aspiration of Gastric Contents, Adverse Effects in the Therapeutic Use of Other and Unspecified General Anaesthetics, Pulmonary Aspiration During Anaesthetic Induction
Keywords
preoperative care, maltodextrine, glutamine, gastric residual volume, MRI

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maltodextrin
Arm Type
Active Comparator
Arm Description
The volunteers ingested 400ml (4 hours before the exam was carried out) at 8:00AM and 200ml (2 hours before the exam was carried out) at 10:00AM of a beverage containing water plus 12.5% maltodextrin
Arm Title
Glutamine
Arm Type
Experimental
Arm Description
The same volunteers ingested 400ml (4 hours before the exam was carried out) at 8:00AM and 200ml (2 hours before the exam was carried out) at 10:00AM of a beverage containing water plus 12.5% maltodextrin plus 15g of glutamine
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Other Intervention Name(s)
Maltodestrin plus glutamine
Intervention Description
The volunteers underwent MRI after the ingestion of the dietary supplement in a crossover fashion aiming at measuring the gastric residual volume
Intervention Type
Dietary Supplement
Intervention Name(s)
Glutamine
Intervention Description
The volunteers ingested 400ml (4 hours before the exam was carried out) at 8:00AM and 200ml (2 hours before the exam was carried out) at 10:00AM of a beverage containing water plus 12.5% maltodextrin plus 15g of GLN before MRI
Primary Outcome Measure Information:
Title
Gastric residual volume (GVR) ("change" is being assessed)
Description
We measured the GRV by MRI immediately after ingestion (T0)and the changes of GVR after 120 (T120)and 180 minutes (T180)- "change" is being assessed
Time Frame
immediately after ingestion (T0), 120 minutes after (T120) and 180 (T180) minutes after ingestion
Secondary Outcome Measure Information:
Title
Vomiting
Description
We observed whether the volunteer presented vomiting during the experiment
Time Frame
180 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Young male volunteers (aged between 21 and 30 years-old) with body mass index (BMI) between 20 and 29 kg/m2 and without either acute or chronic illness in the last 3 months. Exclusion Criteria: non-adherence to any phase of the study protocol, gastroesophageal reflux disease, previous history of intolerance to lactose, gastroparesis or history of poor gastric emptying, diabetes mellitus, and previous abdominal surgery
Facility Information:
Facility Name
Hospital Santa Rosa
City
Cuiaba
State/Province
Mato Grosso
ZIP/Postal Code
78000-000
Country
Brazil

12. IPD Sharing Statement

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Safety of Gastric Volume Emptying After the Intake of Maltodextrin and Glutamine

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