How do You Take Your Coffee Before Anesthesia

NCT ID: NCT04786691

Last Updated: 2023-03-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia Aspiration Fasting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized Controlled Crossover
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The investigators performing the gastric ultrasound will be blinded to which arm of the study the participant is currently in.

Study Groups

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Black coffee first

12 oz of black coffee with no additives is the first intervention tested

Group Type PLACEBO_COMPARATOR

Addition of half and half to coffee

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

No Creamer

Coffee with half and half first

12 oz of black coffee with 1 oz of half and half is the first intervention tested

Group Type ACTIVE_COMPARATOR

Addition of half and half to coffee

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

No Creamer

Coffee with non-dairy creamer first

12 oz of black coffee with 1 oz of liquid non-dairy creamer is the first intervention tested

Group Type ACTIVE_COMPARATOR

Addition of half and half to coffee

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

No Creamer

Interventions

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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

Intervention Type OTHER

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

Intervention Type OTHER

Black

No Creamer

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jessica Yeh, MBBS

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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262000

Identifier Type: -

Identifier Source: org_study_id

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