How do You Take Your Coffee Before Anesthesia

NCT04786691 | Completed Results

• 1 other identifier: 262000
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Aspiration; Fasting

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Black coffee first

PLACEBO COMPARATOR

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

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

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

Other: Addition of half and half to coffee; Other: Addition of non-dairy creamer to coffee; Other: Black

Interventions

Addition of half and half to coffee 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

Black coffee first; Coffee with half and half first; Coffee with non-dairy creamer first

Addition of non-dairy creamer to coffee 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 coffee first; Coffee with half and half first; Coffee with non-dairy creamer first

Black OTHER

No Creamer

Black coffee first; Coffee with half and half first; Coffee with non-dairy creamer first

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-65

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72211, United States

Location

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Results Point of Contact

• Title: Jessica Yeh
• Organization: University of Arkansas for Medical Sciences

jyeh@uams.edu

(501) 686-6114

Study Officials

• Jessica Yeh, MBBS

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators performing the gastric ultrasound will be blinded to which arm of the study the participant is currently in.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Crossover

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 8, 2021
• Study Start: March 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: March 23, 2023
• Results First Posted: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)