Gastroesophageal Reflux, Obesity
Conditions
Keywords
Carbohydrate drink, Gastric residual volume, Gastric ultrasound
Brief summary
The goal of this clinical trial is to compare gastric residual volume between drinking a carbohydrate drink and water in obesity class II and III volunteers at risk of aspiration.
Interventions
DIAGNOSTIC_TESTUltrasonography of gastric residual volume
Gastric ultrasound will be performed by the radiologist on each participant before the study and at 0, 10, 20, 30, 60, 90, 120 minutes after drinking in the position of head upright 45 degree with left lateral decubitus to evaluate the gastric residual volume and time to empty gastric antrum. If time to empty gastric antrum is extended, ultrasound will be serial performed at 150 and 180 minutes.
DIAGNOSTIC_TESTPoint-of-care testing of glucose
We will perform the point-of-care test of glucose before the study and at 60, and 120 minutes after drinking.
OTHERHunger numeric rating scale
Hunger will be measured by a numeric rating scale(NRS) before drinking, 60 and 120 minutes after drinking. The Numeric Rating Scale(NRS) is used for the self-report measurement of hunger levels, defined by numbers from 0 to 10, where 0 represents the lowest level of hunger and 10 represents the highest.
OTHERThirst numeric rating scale
Thirst will be measured by a numeric rating scale(NRS) before drinking, 60, and 120 minutes after drinking. The Numeric Rating Scale(NRS) is used for the self-report measurement of thirst levels, defined by numbers from 0 to 10, where 0 represents the lowest level of thirst and 10 represents the highest.
OTHERNausea numeric rating scale
Nausea will be measured by a numeric rating scale(NRS) before drinking, 60, and 120 minutes after drinking. The Numeric Rating Scale(NRS) is used for the self-report measurement of nausea levels, defined by numbers from 0 to 10, where 0 represents the lowest level of nausea and 10 represents the highest.
Sponsors
Prince of Songkla University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI ≥ 35 kg/m2 (obesity class II and III) * Gastroesophageal reflux disease and/or active gastroesophageal reflux symptoms in 6 months (heartburn and/or acid regurgitation) * ASA status I-III * NPO for 8 hours before the study
Exclusion criteria
* Chronic kidney disease or End-stage renal disease * Diabetes Mellitus * Use of any medication that affects gastric secretion or emptying within the past 24-hour * Pregnancy * History of major upper gastrointestinal surgery * Allergy to ultrasound gel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastric Residual Volume | before the study and 0, 10, 20, 30, 60, 90, 120 minutes after drinking the prepared drink each arm.If time to empty gastric antrum is extended, ultrasound will be serial performed at 150 and 180 minutes. | gastric ultrasound at the gastric antrum by ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to empty gastric antrum | 0, 10, 20, 30, 60, 90, 120 minutes after drinking the prepared drink each arm. If participants doesn't be empty stomach, time will extended to 120 and 180 minutes. | Duration after drinking the drink until the gastric antrum cross-sectional area \< 1.5 ml/kg measure by ultrasound |
| Point-of-care testing(POCT) glucose | Point-of-care testing(POCT) glucose is measured before the study, 60 and 120 after drinking the prepared drink each arm. | measured by point-of-care testing(POCT) glucose at every 60 minutes entire the study |
| Hunger Numeric Rating Scale(NRS) | before the study, 60, and 120 minutes after drinking the prepared drink each arm | Hunger will be measured by a numeric rating scale(NRS) before drinking, 60, and 120 minutes after drinking. The Numeric Rating Scale(NRS) is used for the self-report measurement of hunger levels, defined by numbers from 0 to 10, where 0 represents the lowest level of hunger and 10 represents the highest. |
| Thirst Numeric Rating Scale(NRS) | before the study, 60, and 120 minutes after drinking the prepared drink each arm | Thirst will be measured by a numeric rating scale(NRS) before drinking, 60, and 120 minutes after drinking. The Numeric Rating Scale(NRS) is used for the self-report measurement of thirst levels, defined by numbers from 0 to 10, where 0 represents the lowest level of thirst and 10 represents the highest. |
| Nausea Numeric Rating Scale(NRS) | before the study, 60, and 120 minutes after drinking the prepared drink each arm | Nausea will be measured by a numeric rating scale(NRS) before drinking, 60, and 120 minutes after drinking. The Numeric Rating Scale(NRS) is used for the self-report measurement of nausea levels, defined by numbers from 0 to 10, where 0 represents the lowest level of nausea and 10 represents the highest. |
Countries
Thailand
Outcome results
None listed