Clinical trial NCT05244902: Gastric Emptying Times of Normal and Obese Children After Preoperative Clear Fluid Drinking: An Ultrasound Study
Official title: Gastric Emptying Times of Normal and Obese Children After Preoperative Clear Fluid Drinking: An Ultrasound Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Emptying Time
Keywords: Gastric volume
Gastric emptying time
Antral cross-sectional area (ACSA)
Obese pediatric patients
Lead sponsor: Karaman Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 70
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pediatric patients will be divided into two groups as obese and non-obese. Children above the 95% percentile will be considered as obese.
Primary purpose: TREATMENT

Brief summary: In the recent literature, pre-operative fasting times for pediatric patients are limited to one hour for clear fluids. Studies related to gastric emptying times mostly searched for normal-weight children. These studies have claimed that 3 mL/kg clear fluid can be allowed up to 1 hour before surgery. There is a lack of interest in the gastric emptying time of obese pediatric patients during the preoperative period. In addition, there is controversy about gastric emptying times of obese healthy children. Some research committed the decrease of gastric emptying because of a high level of sensitivity to cholecystokinin, while others postulated that no change in gastric emptying time of obese children compared to normal weight. The aim of this trial is to compare the gastric volume and gastric emptying time after ingestion of 3 mL/kg clear fluid in obese and non-obese pediatric patients in the pre-operative period.

Detailed description: After receiving informed consent from the children and their families, American Society of Anesthesiologists (ASA) 1-2 pediatric patients between 6-14 years, who will recruit for elective surgery will be included for this study. The children over 95% percentile will be accepted as obese. After, the basal gastric volume will be calculated with the help of Ultrasonography (USG). The children will receive oral 3 mL/kg(max 250 mL) 5% dextrose .USG evaluation will be made every 5 minutes until the gastric volume reaches the basal level. Children reaching basal gastric volume will be accepted as suitable for the surgery. The aim of this study is to compare the gastric volume and gastric emptying time after ingestion of 3 mL/kg clear fluid in obese and non-obese pediatric patients in the pre-operative period.

Eligibility criteria: Inclusion Criteria:

* ASA physical state I or II
* Age 6 to 14 years.
* Gender: both sexes.
* Scheduled for non-Gastrointestinal Tract elective day-case surgery under general anesthesia.

Exclusion Criteria:

* Parent/ care giver refusal
* Ages \< 6 or \> 14 years old
* Children with gastro-esophageal reflux disease
* Renal failure
* Diabetes mellitus
* Cerebral palsy patients
* Mental retardation
* Esophageal strictures, achalasia or any intestinal disease that may impair the gastric emptying.
* Gastrointestinal system surgery and neurosurgical patients
* Emergency surgery
* Violation of the prescribed fasting times
* Refusing to drink prescribed clear fluid

Primary outcomes:
measure: Gastric emptying time
timeFrame: 90 minute
Secondary outcomes:
measure: Antral cross-sectional area
timeFrame: 90 minute
Other outcomes:
measure: Gastric emptying half-time ( t 1/2)
timeFrame: 90 minute
measure: Gastric volume
timeFrame: 90 minute
Locations:
city: Karaman
country: Turkey
facility: Karaman Taining and Research Hospital
Study officials:
affiliation: Karaman Training and Research Hospital
name: Muhammet Korkusuz, MD
role: PRINCIPAL_INVESTIGATOR
References: