How do You Take Your Coffee Before Anesthesia

• Sponsor: University of Arkansas (Other)
• Overall Status: Completed
• CT.gov ID: NCT04786691
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 3
• Actual Duration (Months): 4
• Patients Per Site Per Month: 4.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Aspiration; Fasting	Other: Addition of half and half to coffee; Other: Addition of non-dairy creamer to coffee; Other: Black	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Randomized Controlled CrossoverRandomized Controlled Crossover
• 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.
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Mar 1, 2021
• Actual Primary Completion Date: Jun 30, 2021
• Actual Study Completion Date: Jun 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in 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. CSA is measured as baseline after fasting for 6 hours and measured again 2 hours after consuming prepared coffee drink

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72211

Sponsors and Collaborators

• University of Arkansas

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Arkansas
• ClinicalTrials.gov Identifier: NCT04786691
• Other Study ID Numbers: 262000
• First Posted: Mar 8, 2021
• Last Update Posted: Aug 5, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 5, 2021