- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05685446
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
Conditions
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:
|
|
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.
Sponsor
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
Keywords
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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