Evaluation of Gastric Volume and pH Changes in Gastroscopy Patients

NCT ID: NCT06842602

Last Updated: 2025-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

405 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-01-01

Brief Summary

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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

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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.

Conditions

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Gastroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Group control

strict fasting rules

Group Type ACTIVE_COMPARATOR

strict fasting rules

Intervention Type OTHER

followed strict fasting rules

Group gum

chewed gum within 2 hours before the procedure

Group Type ACTIVE_COMPARATOR

gum

Intervention Type OTHER

chewed gum within 2 hours before the procedure

Group candy

consumed candy within 2 hours before the procedure

Group Type ACTIVE_COMPARATOR

candy

Intervention Type OTHER

consumed candy within 2 hours before the procedure

Interventions

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gum

chewed gum within 2 hours before the procedure

Intervention Type OTHER

candy

consumed candy within 2 hours before the procedure

Intervention Type OTHER

strict fasting rules

followed strict fasting rules

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mehmet Fatih Erol

m.d

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mehmet fatih erol, M.D

Role: STUDY_DIRECTOR

Bursa Yuksek ıhtısas tra

Füsun gözen, M.D

Role: STUDY_DIRECTOR

Bursa Yuksek Ihtısas tranin and research hospital

Locations

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Mehmet Fatih Erol

Bursa, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2023/07-11

Identifier Type: -

Identifier Source: org_study_id

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