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Completed

NCT Number: NCT06842602

Evaluation of Gastric Volume and pH Changes in Gastroscopy Patients

Pulmonary aspiration is a rare but serious complication that can result in 57% mortality and 14% permanent damage. Fasting rules (solid foods 6-8 hours, clear liquids 2 hours) determined by anesthesia associations are applied to prevent pulmonary aspiration by reducing gastric volume. Gastric volume (≥ 0.5 mL/kg) and pH (<2.5) values are shown to be determinants in the occurrence of pulmonary complications .

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Key information

Conditions

Gastroscopy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mehmet Fatih Erol

Bursa, 16400, Turkey (Türkiye)

About this study

The hypothesis of this study was that preprocedure candy and chewing gum use may have no effects on gastric residual volume and pH. For this purpose, we analyzed the gastric residual volume and gastric pH values of patients who were given gum and candy before the procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I-III,
  • oriented
  • cooperative
  • scheduled for elective gastroscopy

Exclusion criteria

  • body mass index is (BMI) >30 kg/m2,
  • full stomach predicted patients (obstruction, stenosis, bleeding, ascites, urgency),
  • patients with diabetes
  • patients with who underwent bowel cleansing
  • patients who did not want to give consent to participate

Treatment and study plan

Gum

Other

chewed gum within 2 hours before the procedure

candy

Other

consumed candy within 2 hours before the procedure

strict fasting rules

Other

followed strict fasting rules

Primary outcomes

  1. Gastric volume

    Time frame: baseline

    No washing was performed during the insertion and advancement of the endoscope. The entire gastric volume were aspirated into a scaled container (medbar collection container). The amount of collected samples was recorded .

  2. Gastric pH measurements

    Time frame: baseline

    No washing was performed during the insertion and advancement of the endoscope. The entire gastric contents were aspirated into a scaled container (medbar collection container). The amount of collected samples was recorded and pH analysis (WTW inoLab® pH 7310 Table Type pH Meter) was performed.

Secondary outcomes

  1. endoscopist satisfaction

    Time frame: baseline

    At the end of the procedure, endoscopist satisfaction (0=unsatisfied 1=abstained 2=satisfied) and procedure difficulty (0=easy 1=normal 2=difficult)

  2. general procedure satisfaction

    Time frame: baseline

    Before discharge, general procedure satisfaction (0=unsatisfied, 1=abstained, 2=satisfied), product satisfaction (0=unsatisfied, 1=abstained, 2=satisfied), product effects (1=increase in hunger, 2=increase in thirst, 3=increase in dyspepsia, 4=abstained, 5= decrease in hunger, 6= decrease in thirst, 7= decrease in dyspepsia)

  3. Complication

    Time frame: Perioperative

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

Evaluation of Gastric Volume and pH Changes in Gastroscopy Patients Using Chewing Gum and Candy: Prospective Randomized Double-Blind Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 24, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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