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临床试验/NCT03948594
NCT03948594Unknown不适用

The Effect of Carbohydrate Loading on Gastric Residual Volume and Hunger Score: A Single Blind, Randomised Controlled Trial Study

Universiti Sains Malaysia0 个研究点目标入组 78 人开始时间: 2019年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
78
主要终点
gastric residual volume

研究概览

简要总结

This study conducted is to assess effect of carbohydrate loading (maltodextrin with whey protein) to gastric volume 2 hours after ingestion via aspiration while doing OGDS (direct visualisation) and patient's wellbeing (hunger, thirst, weakness, tiredness, anxiety) for all patient planned for OGDS.

hypothesis H1: There is significant association between carbohydrate loading with residual gastric volume and subject's wellbeing H0: there is no significant association between carbohydrate loading with gastric residual volume and subject's wellbeing

详细描述

Patient scheduled for elective OGDS in HUSM from April 2019 to December 2019 with the complaint of one or more of the following symptoms: Bothersome postprandial fullness, early satiation, Epigastric pain or Epigastric burning are eligible to participate in the study. Patients who fulfilled exclusion criteria (History of upper gastrointestinal surgery, intestinal obstruction, patient with vomiting or mentally disable or who cannot give an informed consent) are ineligible.

If a patient fulfils the inclusion criteria, a suitable medical officer will discuss the trial with patient while reviewing patient in surgical outpatient clinic prior to OGDS. Patient will be approached again on the day of OGDS, if patient agree to participate in study, a written consent will be obtained. If patient refuse to participate in study, appropriate treatment and care still will be provided to patient. The consent form will provide information about the purpose of the study, the procedures to be followed, risks and benefits of participation. If patient agree to participate in the trial, subject will be enrolled in the study. Method of recruitment in this study is direct recruitment of potential study participants.

Stratified permuted block randomization was used. Randomization sequence was created using https://www.sealedenvelope.com/simple-randomiser/v1/lists and is stratified by gender (female and male) with 1:1 allocation. Random block sizes of 6 is used.

Allocation sequence is according computer generated random number list, it was prepared by an investigator with no clinical involvement in the trial. Allocation sequence was concealed from researcher enrolling and assessing participants. Allocation sequence will be sealed in sequentially numbered and opaque envelopes. A manila card will be placed inside envelop to render it impermeable to intense light. To prevent subversion of the allocation sequence, the name and I/C of the participant will be written on a book together with the series number on envelopes. The details in the book will be kept confidentially. After enrolled subject complete all baseline assessment, corresponding envelope will be enclosed by staff (who not involve in study) who prepare the drink. The staff need to ensure that the envelop still sealed when receive it. The staff will prepare the drink into identical container according to the assignment

Subjects are randomised into 2 group: group A with 250cc plain water and group B give 1 packet resource(237ml). Subjects need to finish the drink over 10minutes. After that, subjects are not allow to leave endoscope room before OGDS done to prevent consumption of other drink or food.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

盲法说明

Allocation sequence is according computer generated random number list, it was prepared by an investigator with no clinical involvement in the trial. Allocation sequence was concealed from researcher enrolling and assessing participants. Allocation sequence will be sealed in sequentially numbered and opaque envelopes. A manila card will be placed inside envelop to render it impermeable to intense light. To prevent subversion of the allocation sequence, the name and I/C of the participant will be written on a book together with the series number on envelopes. The details in the book will be kept confidentially. After enrolled subject complete all baseline assessment, corresponding envelope will be enclosed by staff (who not involve in study) who prepare the drink. The staff need to ensure that the envelop still sealed when receive it. The staff will prepare the drink into identical container according to the assignment.

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient more than 18 years old

排除标准

  • History of upper gastrointestinal surgery
  • Intestinal obstruction
  • Patient with vomiting
  • Mentally disable or who cannot give an informed consent

研究组 & 干预措施

plain water

Placebo Comparator

subject drink 250cc plain water

干预措施: plain water (Other)

resource

Active Comparator

subject drink 1 packet resource(237ml)

干预措施: resource (Dietary Supplement)

结局指标

主要结局

gastric residual volume

时间窗: 2 hours after plain water or carbohydrate loading

Amount of gastric residual volume (ml) that has been aspirated via OGDS 2 hours after plain water or carbohydrate loading group

次要结局

  • patient's wellbeing(baseline (before drink) and 120minutes after drinking)

研究者

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

Bee Chen Lua

principal investigator

Universiti Sains Malaysia

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