Anesthesia, Aspiration, Fasting
Conditions
Brief 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.
Interventions
OTHERAddition 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
OTHERAddition 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
OTHERBlack
No Creamer
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The investigators performing the gastric ultrasound will be blinded to which arm of the study the participant is currently in.
Intervention model description
Randomized Controlled Crossover
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between Gastric Volume Post Coffee Consumption Compared to the Baseline Gastric Volume | Baseline 6 hours after fasting and 2 hours after intervention | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All study participants were randomized to receive all 3 interventions of consumption of black coffee, coffee with half and half, and coffee with non-dairy creamer. | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 18 Participants | — |
| Body Mass Index | 22.4 kg/m^2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 18 participants | — |
| Sex: Female, Male Female | 11 Participants | — |
| Sex: Female, Male Male | 7 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 0 / 18 | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 | 0 / 18 |
Outcome results
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
Time frame: Baseline 6 hours after fasting and 2 hours after intervention
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Black Coffee | Difference Between Gastric Volume Post Coffee Consumption Compared to the Baseline Gastric Volume | 13 milliliters |
| Coffee With Half and Half | Difference Between Gastric Volume Post Coffee Consumption Compared to the Baseline Gastric Volume | 5 milliliters |
| Coffee With Non-dairy Creamer | Difference Between Gastric Volume Post Coffee Consumption Compared to the Baseline Gastric Volume | -1.5 milliliters |