ltrasound assessment for comparison of Gastric Residual Volume after Ingestion of Carbohydrate Drink and Water in Obesity class II and III Volunteers at risk of aspiration: A Randomized Crossover Study
Phase 1
Recruiting
- Conditions
- Age between 18 to 65 years oldBMI at least 35 kg per m2Gastroesophageal reflux disease or active gastroesophageal reflux symptoms in 6 months (heartburn and/or acid regurgitation)ASA status I-IIINPO for 8 hours before the studyCarbohydrate drink, Gastric residual volume, Gastric ultrasound, Morbid obese volunteers, Gastroesophageal reflux disease
- Registration Number
- TCTR20240601006
- Lead Sponsor
- Faculty of Medicine, Prince of Songkla University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
1.Age between 18 to 65 years old
2.BMI at least 35 kg per m2
3.Gastroesophageal reflux disease or active gastroesophageal reflux symptoms in 6 months (heartburn and/or acid regurgitation)
4.ASA status I-III
5.NPO for 8 hours before the study
Exclusion Criteria
Chronic kidney disease or End-stage renal disease
Diabetes Mellitus
1.Use of any medication that affects gastric secretion or emptying within the past 24-hour
2.Pregnancy
3.History of major upper gastrointestinal surgery
4.Allergy to ultrasound gel
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gastric Residual Volume 120 minute after drink Ultrasound measurement
- Secondary Outcome Measures
Name Time Method Time to empty gastric antrum when gastric residual volume is less than 1.5 ml/kg Ultrasound measurement,Blood glucose 60, 120, 180 minute after drink Blood Glucose Meter,Hunger 60, 120, 180 minute after drink Verbal Numeric Rating Scale,Thirst 60, 120, 180 minute after drink Verbal Numeric Rating Scale,Nausea 60, 120, 180 minute after drink Verbal Numeric Rating Scale