NCT05827029

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

April 24, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

April 9, 2023

Last Update Submit

April 21, 2023

Conditions

ObesityGastric Emptying

Keywords

gastric residual volume, obesity, carbohydrate drink

Outcome Measures

Primary Outcomes (1)

  • gastric residual volume

    changes in gastric residual volume during 2 hours after drinking

    baseline and every 30 minutes until 2 hours after drinking

Secondary Outcomes (3)

  • time to empty gastric antrum

    baseline and 120 minutes after drinking

  • POCT glucose

    baseline and 120 minutes after drinking

  • thirst and hunger level

    baseline and 120 minutes after drinking

Study Arms (2)

Preoperative carbohydrate drink

EXPERIMENTAL
Procedure: Preopertive drink

Water

PLACEBO COMPARATOR
Procedure: Preopertive drink

Interventions

Preopertive drinkPROCEDURE

* Group C: will receive a carbohydrate drink of 400 ml (50 g of glucose prepared by nutrition division, same appearance and containing bottles of water) * Group W: will receive water 400 ml (prepared by nutrition division, Songklanagarind hospital, same appearance and containing bottles of carbohydrate drink) In both groups, the received 400-mL drink was consumed within 5 minutes. * Before drinking, baseline data (gastric residual volume, POCT glucose, degree of hunger, and thirst) will be evaluated. * Gastric ultrasound will be performed by the same Radiologist on each participant at 0, 30, 60, 90, 120 minutes * after drinking to evaluate the gastric residual volume and time to empty gastric antrum. * POCT glucose and degree of hunger and thirst are also assessed again at 120 minutes after drinking. * After completing one type of drinking, participants will be appointed again after 1 week later for doing the same protocol with another drinking.

Preoperative carbohydrate drinkWater

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Faculty pf Medicine

Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chanatthee Kitsiripant

    Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst.Prof.

Study Record Dates

First Submitted

April 9, 2023

First Posted

April 24, 2023

Study Start

April 1, 2023

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

April 24, 2023

Record last verified: 2023-04

Locations

TH(1)