How do You Take Your Coffee Before Anesthesia

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Fasting; Aspiration
• Intervention / Treatment: Other: Addition of half and half to coffee; Other: Addition of non-dairy creamer to coffee; Other: Black

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Black coffee first; 12 oz of black coffee with no additives is the first intervention tested	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; 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; Other: Black; No Creamer
Active Comparator: Coffee with half and half first; 12 oz of black coffee with 1 oz of half and half is the first intervention tested	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; 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; Other: Black; No Creamer
Active Comparator: Coffee with non-dairy creamer first; 12 oz of black coffee with 1 oz of liquid non-dairy creamer is the first intervention tested	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; 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; Other: Black; No Creamer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Jessica Yeh, MBBS, University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 262000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No