Recommended Clear Fluid Intake Volume at 2 Hours Prior to Esophagogastroduodenoscopy for Adult Patients

NCT04501393 | Unknown

• 1 other identifier: 382/2563
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

Research in developing patient fasting guidelines was developed years ago. On a physiological basis, patients with a longer fasting time may have less residual gastric content and lower risk of pulmonary aspiration. The recent Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration of The American Society of Anesthesiologists (ASA) was published in March 2017. Current practice consists of 2-hour fasting period for clear oral fluid (including water, pulp-free juice and tea or coffee without milk), 4- hour fasting period for breast milk and 6-hour fasting period for non-human milk and solid food. However, there are only few supportive and suggestive scientific evidences. The purpose of this study is to evaluate the current clinical practice guidelines for preoperative fasting to enhance the quality of pediatric anesthesia care and promote patient safety.The investigators plan to enroll adults aged 18-60 years, who are scheduled for esophago-gastro-duodenoscopy (EGD), in order to study the effects of fasting time and the actual intragastric volume which may help us establish a comprehensive fasting guideline.

Conditions

Fasting

Outcome Measures

Primary Outcomes (1)

• Residual gastric volume

  Collect actual intra-gastric content volume after drinking assigned amount of fluid at 2-hour fasting period of each patient.

  at 2 hour after drinking, during endoscopic procedure

Secondary Outcomes (4)

• Gastric acidity (pH)

  at 2 hour after drinking, during endoscopic procedure

• Hypotension

  at 2 hour after drinking, during endoscopic procedure

• Post operative nausea and vomitting

  pre-endoscopic procedure

• Ready to discharge time

  When the procedure finish until ready to discharge, approximately 1-2 hours after endoscopy

Study Arms (4)

0 ml/kg

NO INTERVENTION

The participants will not be asked to drink anything at 2 hours prior to planned procedure.

3 ml/kg

ACTIVE COMPARATOR

The participants will be asked to drink 3ml/kg of clear liquid at 2 hours prior to planned procedure.

Other: Clear liquid intake

7 ml/kg

ACTIVE COMPARATOR

The participants will be asked to drink 7 ml/kg of clear liquid at 2 hours prior to planned procedure.

Other: Clear liquid intake

10 ml/kg

ACTIVE COMPARATOR

The participants will be asked to drink 10 ml/kg of clear liquid at 2 hours prior to planned procedure.

Other: Clear liquid intake

Interventions

Clear liquid intake OTHER

Clear oral fluid including water, pulp-free juice and tea or coffee without milk

10 ml/kg; 3 ml/kg; 7 ml/kg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who are 18-60 years scheduled for EGD procedure
• Patient who willing to participate in this study

You may not qualify if:

• Patient who scheduled for emergent EGD procedures
• Patients with active upper GI bleeding
• Patients who received preoperative oral medication
• BMI \> 30 kg/m2
• Patients with previous GI motility or acid-base pathology

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine, Siriraj hospital

Bangkok Noi, Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Central Study Contacts

Sirirat Rattanaarpa, MD

CONTACT

024197989; rattanaarpa.s@gmail.com

Patcharee Sriswasdi, MD, MPH

CONTACT

024197989; pat.si.research@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 6, 2020
• Study Start: September 1, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)