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临床试验/NCT04786691
NCT04786691已完成不适用

How do You Take Your Coffee Before Anesthesia: A Randomized Controlled Crossover Study Comparing Gastric Emptying With Black Coffee vs Coffee With Cream

University of Arkansas1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
Difference Between Gastric Volume Post Coffee Consumption Compared to the Baseline Gastric Volume

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age between 18-65

排除标准

  • •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

研究组 & 干预措施

Black coffee first

Placebo Comparator

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

干预措施: Addition of half and half to coffee (Other)

Black coffee first

Placebo Comparator

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

干预措施: Addition of non-dairy creamer to coffee (Other)

Black coffee first

Placebo Comparator

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

干预措施: Black (Other)

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

干预措施: Addition of half and half to coffee (Other)

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

干预措施: Addition of non-dairy creamer to coffee (Other)

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

干预措施: Black (Other)

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

干预措施: Addition of half and half to coffee (Other)

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

干预措施: Addition of non-dairy creamer to coffee (Other)

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

干预措施: Black (Other)

结局指标

主要结局

Difference Between Gastric Volume Post Coffee Consumption Compared to the Baseline Gastric Volume

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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