Trial Outcomes & Findings for How do You Take Your Coffee Before Anesthesia (NCT NCT04786691)
NCT ID: NCT04786691
Last Updated: 2023-03-23
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
Baseline 6 hours after fasting and 2 hours after intervention
Results posted on
2023-03-23
Participant Flow
Participant milestones
| Measure |
1-Black Coffee, 2-half and Half, 3-creamer
12 oz of black coffee with no additives is given to participants assigned to this arm first after the baseline gastric ultrasound. Based on the randomization order, participants will then participate in the coffee with half and half arm and then the coffee with non-dairy creamer arm.
|
1-Black Coffee, 2-creamer, 3-half and Half
12 oz of black coffee with no additives is given to participants assigned to this arm first after the baseline gastric ultrasound. Based on the randomization order, participants will then participate in the coffee with non-dairy creamer arm then coffee with half and half.
|
1-half and Half, 2-black Coffee, 3-creamer
12 oz of black coffee with 1 oz of half and half is given to participants assigned to this arm first after the baseline gastric ultrasound. Based on the randomization order, participants will then participate in the black coffee arm and the coffee with non-dairy creamer arm.
|
1-half and Half, 2-creamer, 3-black Coffee
12 oz of black coffee with 1 oz of half and half is given to participants assigned to this arm first after the baseline gastric ultrasound. Based on the randomization order, participants will then participate in the coffee with non-dairy creamer arm then the black coffee arm.
|
1-creamer, 2-black Coffee, 3-half and Half
12 oz of black coffee with 1 oz of liquid non-dairy creamer is given to participants assigned to this arm first after the baseline gastric ultrasound. Based on the randomization order, participants will then participate in the black coffee arm then the coffee with half and half arm.
|
1-creamer, 2-half and Half, 3-black Coffee
12 oz of black coffee with 1 oz of liquid non-dairy creamer is given to participants assigned to this arm first after the baseline gastric ultrasound. Based on the randomization order, participants will then participate in the coffee with half and half arm then the black coffee arm.
|
|---|---|---|---|---|---|---|
|
First Intervention (2 Hours)
STARTED
|
2
|
3
|
2
|
4
|
3
|
4
|
|
First Intervention (2 Hours)
COMPLETED
|
2
|
3
|
2
|
4
|
3
|
4
|
|
First Intervention (2 Hours)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period (2 Days)
STARTED
|
2
|
3
|
2
|
4
|
3
|
4
|
|
Washout Period (2 Days)
COMPLETED
|
2
|
3
|
2
|
4
|
3
|
4
|
|
Washout Period (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention (2 Hours)
STARTED
|
2
|
3
|
2
|
4
|
3
|
4
|
|
Second Intervention (2 Hours)
COMPLETED
|
2
|
3
|
2
|
4
|
3
|
4
|
|
Second Intervention (2 Hours)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention (2 Hours)
STARTED
|
2
|
3
|
2
|
4
|
3
|
4
|
|
Third Intervention (2 Hours)
COMPLETED
|
2
|
3
|
2
|
4
|
3
|
4
|
|
Third Intervention (2 Hours)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=18 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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=18 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=18 Participants
|
|
Body Mass Index
|
22.4 kg/m^2
n=18 Participants
|
PRIMARY outcome
Timeframe: Baseline 6 hours after fasting and 2 hours after interventionGastric 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
Outcome measures
| Measure |
Black Coffee
n=18 Participants
12 oz of black coffee with no additives given to participants after the baseline gastric ultrasound either as the first, second, or third intervention.
|
Coffee With Half and Half
n=18 Participants
12 oz of black coffee with 1 oz of half and half given to participants after the baseline gastric ultrasound either as the first, second, or third intervention.
|
Coffee With Non-dairy Creamer
n=18 Participants
12 oz of black coffee with 1 oz of liquid non-dairy creamer given to participants after the baseline gastric ultrasound either as the first, second, or third intervention.
|
|---|---|---|---|
|
Difference Between Gastric Volume Post Coffee Consumption Compared to the Baseline Gastric Volume
|
13 milliliters
Interval -0.6 to 26.6
|
5 milliliters
Interval -8.6 to 18.6
|
-1.5 milliliters
Interval -15.1 to 12.1
|
Adverse Events
Black Coffee
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Coffee With Half and Half
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Coffee With Non-dairy Creamer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jessica Yeh
University of Arkansas for Medical Sciences
Phone: (501) 686-6114
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place