AnesthesiaNCT04786691
How do You Take Your Coffee Before Anesthesia
A study testing Addition of half and half to coffee, Addition of non-dairy creamer to coffee and Black in people with Anesthesia and Aspiration, run by University of Arkansas at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Aspiration, Fasting
- What is being tested?
- Addition of half and half to coffee, Addition of non-dairy creamer to coffee and Black
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18-65
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72211
About this study
Official title: How do You Take Your Coffee Before Anesthesia: A Randomized Controlled Crossover Study Comparing Gastric Emptying With Black Coffee vs Coffee With Cream
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.
- Conditions
- Anesthesia, Aspiration, Fasting
- Being tested
- Addition of half and half to coffee, Addition of non-dairy creamer to coffee, Black
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Addition of half and half to coffeeOther
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 coffeeOther
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
BlackOther
No Creamer
| Study group | Role | What they receive |
|---|---|---|
| Black coffee first | Placebo comparator | 12 oz of black coffee with no additives is the first intervention tested Receives: Other: Addition of half and half to coffee; Other: Addition of non-dairy creamer to coffee; Other: Black |
| Coffee with half and half first | Active comparator | 12 oz of black coffee with 1 oz of half and half is the first intervention tested Receives: Other: Addition of half and half to coffee; Other: Addition of non-dairy creamer to coffee; Other: Black |
| Coffee with non-dairy creamer first | Active comparator | 12 oz of black coffee with 1 oz of liquid non-dairy creamer is the first intervention tested Receives: Other: Addition of half and half to coffee; Other: Addition of non-dairy creamer to coffee; Other: Black |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline 6 hours after fasting and 2 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Mar 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized Controlled Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Yeh, MBBS, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786691
- Sponsor's protocol ID
- 262000
- Status last verified
- Mar 2023
- First submitted
- 3 Mar 2021
- Last updated
- 23 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How do You Take Your Coffee Before Anesthesia: A Randomized Controlled Crossover Study Comparing Gastric Emptying With Black Coffee vs Coffee With Cream
- ClinicalTrials.gov ID
- NCT04786691
- Acronym / sponsor ID
- 262000
- Conditions
- Anesthesia, Aspiration, Fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 8 Mar 2021 (actual)
- Results
- Posted 23 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized Controlled Crossover
| Arm | Type | Receives |
|---|---|---|
| Black coffee first | Placebo comparator | Other: Addition of half and half to coffee, Other: Addition of non-dairy creamer to coffee, Other: Black12 oz of black coffee with no additives is the first intervention tested |
| Coffee with half and half first | Active comparator | Other: Addition of half and half to coffee, Other: Addition of non-dairy creamer to coffee, Other: Black12 oz of black coffee with 1 oz of half and half is the first intervention tested |
| Coffee with non-dairy creamer first | Active comparator | Other: Addition of half and half to coffee, Other: Addition of non-dairy creamer to coffee, Other: Black12 oz of black coffee with 1 oz of liquid non-dairy creamer is the first intervention tested |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age between 18-65
Key exclusion criteria (6 listed)
- Diabetes mellitus
- Delayed gastric emptying
- Previous gastric surgery
- Lactose intolerance
- Current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Addition of half and half to coffee1 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 | Other | Black coffee first, Coffee with half and half first, Coffee with non-dairy creamer first |
| Addition of non-dairy creamer to coffee1 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 | Other | Black coffee first, Coffee with half and half first, Coffee with non-dairy creamer first |
| BlackNo Creamer | Other | Black coffee first, Coffee with half and half first, Coffee with non-dairy creamer first |
Primary outcome
Difference Between Gastric Volume Post Coffee Consumption Compared to the Baseline Gastric Volume
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Yeh, MBBS principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Addition of half and half to coffee, Addition of non-dairy creamer to coffee and Black in people with Anesthesia and Aspiration, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference Between Gastric Volume Post Coffee Consumption Compared to the Baseline Gastric Volume (time frame: Baseline 6 hours after fasting and 2 hours after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.