Gastric Volume After Drinking 175 ml of Ice Water Prior to Gastroscopy in Healthy Adult Patients

January 5, 2023 updated by: Caroline Hornnes Pedersen, Vendsyssel Hospital

Gastric Emptying and Gastric Volume After Ingestion of 175 ml of Ice Water Prior to Elective Gastroscopy in Healthy Adults

Recommendation for fluid fasting is two hours prior to anaesthesia, however, less may be acceptable. The current study compares ingestion of 175 ml ice water prior to elective gastroscopy vs. standard fasting on gastric residual volume.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Recommendations regarding fasting requirements prior to general anaesthesia is two hours for fluids. Recent research indicates that reduced fluid fasting time may be acceptable. The current study aimed to compare ingestion of 175 ml ice water 15 minutes prior to procedure compared to standardized fasting regimen on residual gastric volumes in patients receiving elective gastroscopy, as these volumes may have implications for fasting requirements.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Denmark
      • Hjørring, North Denmark, Denmark, 9800
        • Department of Anaestesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Scheduled for elective gastroscopy in a medical outpatient clinic
  • American Society of Anesthesiologists physical status classification system category (ASA score) I or II
  • Age 18 years or above

Exclusion Criteria:

  • Any increased risk of aspiration, eg. dysphagia, previous aspiration, non-fasting status, or known alcohol abuse
  • Suspected delayed gastric emptying, eg. regular opioid use within three days
  • Enteral pre-medication required
  • Any structural gastric or esophageal diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 175 ml ice water
Ingestion of 175 ml ice water 15 minutes prior to gastroscopy
Ingestion of 175 ml iced tap water 15 minutes prior to elective gastroscopy
Other Names:
  • Iced tap water
No Intervention: Fasting
Continued fasting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric residual volume
Time Frame: 15 minutes
Aspired residual gastric fluid volume at start of gastroscopy
15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nausea and dyspepsia
Time Frame: 15 minutes
Proportion of patients reporting nausea or dyspeptic symptoms prior to gastroscopy
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Kjeld Damgaard, MD, PhD, Regional Hospital of Northern Denmark, Hjørring

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2020

Primary Completion (Actual)

June 17, 2021

Study Completion (Actual)

June 17, 2021

Study Registration Dates

First Submitted

January 5, 2023

First Submitted That Met QC Criteria

January 5, 2023

First Posted (Estimate)

January 16, 2023

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 5, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • N-20190056

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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