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临床试验/NCT05827029
NCT05827029进行中(未招募)不适用

Comparison of Gastric Residual Volume After Ingestion of Carbohydrate Drink and Water in Obese Volunteers: A Randomized Crossover Study

Prince of Songkla University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年4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
进行中(未招募)
入组人数
30
试验地点
1
主要终点
gastric residual volume

研究概览

简要总结

This randomized crossover study compares gastric residual volume after ingestion of carbohydrate drinks and water in obese volunteers. The main question[s] it aims to answer are:

  • Is it safe for obese patients to shorten their fasting by allowing preoperative drinks?
  • How long is the gastric emptying time in obese patients? Participants also will be evaluated the level of thirst/hungry and blood sugar.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Screening
盲法
Triple (Participant, Investigator, Outcomes Assessor)

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

  • •Healthy volunteers
  • •Age 18 - 65 years old
  • •BMI ≥ 30 kg/m2
  • •NPO for at least 6 hours before the study

排除标准

  • •Diabetes Mellitus
  • •Chronic kidney disease or End-stage renal disease
  • •Use of any medication that affects gastric secretion or emptying (Histamine 2 receptor antagonist eg. Ranitidine/Proton pump inhibitor eg. Omeprazole/Acid neutralization eg. Aluminium hydroxide/Prokinetic eg. Domperidone) within the past 24 hours
  • •Gastroesophageal reflux disease
  • •Pregnancy
  • •History of upper gastrointestinal surgery
  • •In diet program or use appetite suppressant drug (eg. Liraglutide, Naltrexone, Phentermine, Diethylpropion) within the past 24 hours

研究组 & 干预措施

Water

Placebo Comparator

干预措施: Preopertive drink (Procedure)

Preoperative carbohydrate drink

Experimental

干预措施: Preopertive drink (Procedure)

结局指标

主要结局

gastric residual volume

时间窗: baseline and every 30 minutes until 2 hours after drinking

changes in gastric residual volume during 2 hours after drinking

次要结局

  • POCT glucose(baseline and 120 minutes after drinking)
  • thirst and hunger level(baseline and 120 minutes after drinking)
  • time to empty gastric antrum(baseline and 120 minutes after drinking)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chanatthee Kitsiripant

Asst.Prof.

Prince of Songkla University

研究点 (1)

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