Evaluation of Gastric Volume and pH Changes in Gastroscopy Patients

Bursa Yüksek İhtisas Education and Research Hospital

Status: Completed

Conditions: Gastroscopy

Treatments: Other: candy; Other: strict fasting rules; Other: gum

Study type: Interventional

Funder types: Other

Identifiers

NCT06842602

2023/07-11

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 405 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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405 participants in 3 patient groups

Group control

Active Comparator group

Description:

strict fasting rules

Treatment:

Other: strict fasting rules

Group gum

Active Comparator group

Description:

chewed gum within 2 hours before the procedure

Treatment:

Other: gum

Group candy

Active Comparator group

Description:

consumed candy within 2 hours before the procedure

Treatment:

Other: candy