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

Sponsor
Vendsyssel Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05685446
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
15.5
Actual Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Ice water
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Gastric Emptying and Gastric Volume After Ingestion of 175 ml of Ice Water Prior to Elective Gastroscopy in Healthy Adults
Actual Study Start Date :
Mar 3, 2020
Actual Primary Completion Date :
Jun 17, 2021
Actual Study Completion Date :
Jun 17, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 175 ml ice water

Ingestion of 175 ml ice water 15 minutes prior to gastroscopy

Other: Ice water
Ingestion of 175 ml iced tap water 15 minutes prior to elective gastroscopy
Other Names:
  • Iced tap water

    		•
    No Intervention: Fasting

    Continued fasting

    Outcome Measures

    Primary Outcome Measures

    1. Gastric residual volume [15 minutes]

      Aspired residual gastric fluid volume at start of gastroscopy

    Secondary Outcome Measures

    1. Nausea and dyspepsia [15 minutes]

      Proportion of patients reporting nausea or dyspeptic symptoms prior to gastroscopy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anaestesia Hjørring North Denmark Denmark 9800

    Sponsors and Collaborators

    • Vendsyssel Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Caroline Hornnes Pedersen, MD, Vendsyssel Hospital
    ClinicalTrials.gov Identifier:
    NCT05685446
    Other Study ID Numbers:
    • N-20190056
    First Posted:
    Jan 17, 2023
    Last Update Posted:
    Jan 17, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Caroline Hornnes Pedersen, MD, Vendsyssel Hospital
    Gastroscopy
    Gastric volume
    Anaesthesia

    Study Results

    No Results Posted as of Jan 17, 2023