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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05685446
Other study ID # N-20190056
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 3, 2020
Est. completion date June 17, 2021

Study information

Verified date January 2023
Source Vendsyssel Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date June 17, 2021
Est. primary completion date June 17, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Fasting
  • Perioperative Pulmonary Aspiration

Intervention

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

Locations

Country Name City State
Denmark Department of Anaestesia Hjørring North Denmark

Sponsors (1)

Lead Sponsor Collaborator
Vendsyssel Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gastric residual volume Aspired residual gastric fluid volume at start of gastroscopy 15 minutes
Secondary Nausea and dyspepsia Proportion of patients reporting nausea or dyspeptic symptoms prior to gastroscopy 15 minutes
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