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Evaluation of Gastric Volume and pH Changes in Gastroscopy Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06842602
Enrollment
405
Registered
2025-02-24
Start date
2023-01-01
Completion date
2024-01-01
Last updated
2025-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroscopy

Keywords

gastric pH, gastric residual volume, gastroscopy, candy, gum, preoperative fasting rules

Brief summary

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 .

Detailed description

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.

Interventions

OTHERgum

chewed gum within 2 hours before the procedure

OTHERcandy

consumed candy within 2 hours before the procedure

OTHERstrict fasting rules

followed strict fasting rules

Sponsors

Bursa Yuksek Ihtisas Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Gastric volumebaselineNo 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 .
Gastric pH measurementsbaselineNo 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

MeasureTime frameDescription
endoscopist satisfactionbaselineAt the end of the procedure, endoscopist satisfaction (0=unsatisfied 1=abstained 2=satisfied) and procedure difficulty (0=easy 1=normal 2=difficult)
general procedure satisfactionbaselineBefore 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)
ComplicationPerioperative

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026