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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04786691
Other study ID # 262000
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date June 30, 2021

Study information

Verified date March 2023
Source University of Arkansas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Undergoing anesthesia requires patients to fast pre-operatively to allow the stomach to empty and prevent aspiration pneumonia but patients are allowed to drink "clear" liquids up to 2 hours before surgery. Clear liquids are defined as water, carbonated sodas, black coffee or tea without milk or sugar, and juices without pulp. Many Americans prefer to take their coffee with half and half or coffee creamer rather than black. This study will determine whether the addition of a small amount of cream to coffee makes any difference to the volume in the stomach after 2 hours. This study will use healthy volunteers as study participants. Each participant will participate in the study 3 times with at least 2 days in between. We will use a bedside ultrasound machine to measure their stomach content volume at baseline and then they will consume one of 3 different prepare drinks - black coffee, coffee with half and half, or coffee with non-dairy coffee creamer. After 2 hours, we will scan their stomach again and measure stomach content volume and compare it to the first measurement. The participants will repeat this two more times on different days so that they would have had a chance to consume all three prepared coffee drinks in a random order.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Age between 18-65 Exclusion Criteria: - Diabetes mellitus - Delayed gastric emptying - Previous gastric surgery - Lactose intolerance - Current pregnancy - Consumption of solid/liquids in 6 hours prior to commencement of ultrasound study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Addition of half and half to coffee
1 oz of half and half is added to 12 oz of black coffee and given to participants assigned to this arm after the baseline gastric ultrasound
Addition of non-dairy creamer to coffee
1 oz of non-dairy creamer is added to 12 oz of black coffee and given to participants assigned to this arm after the baseline gastric ultrasound
Black
No Creamer

Locations

Country Name City State
United States University of Arkansas for Medical Sciences Little Rock Arkansas

Sponsors (1)

Lead Sponsor Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference Between Gastric Volume Post Coffee Consumption Compared to the Baseline Gastric Volume Gastric volume calculated based on measured cross-sectional area (CSA) of gastric antrum and participant's age. CSA is measured at baseline after fasting for 6 hours and measured again 2 hours after consuming prepared coffee drink Baseline 6 hours after fasting and 2 hours after intervention
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