The Effect of Mobilization on Gastric Emptying Time

NCT05981638 | Completed

• 1 other identifier: 2021-7/26
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

ıntroduction Pulmonary aspiration under general anesthesia is a rare but serious complication in healthy patients undergoing elective surgery. In the preoperative period, negative metabolic, physiological, and/or psychological consequences may occur due to prolonged hunger time (1). It is important to shorten the preoperative fasting period to reduce anxiety and hunger, especially in pediatric patients (2). Material-Methods This study at Bursa Uludag University Hospital (January 2021- January 2022) involved 84 ASA (American Society of Anesthesiologists) class I-III patients aged 4-11 years undergoing elective urogenital surgery, with certain exclusions like gastrointestinal disorders and high BMI (Body Mass Index). Gastric antral area (GAA) was measured with ultrasound (USG) before liquid intake and at various intervals there after; 5, 10, 30, 60, 90 minutes. Patients were split into four groups based on liquid (water or apple juice) and activity level (rest or mobilization). Resting patients watched animations, while mobilized patients were encouraged to walk.

Conditions

Anesthesia; Fasting

Keywords

diagnostic imaging; fasting; anesthesia

Outcome Measures

Primary Outcomes (1)

• Measurement of gastric antral area change with USG within 90 minutes after clear fluid intake

  Ultrasonography (USG) is a non-invasive and reliable imaging method that can be used to measure stomach content. It is widely used to examine the gastric antral cross-sectional area (GAA) (cm2) in adult and pediatric patients.The purpose of this study was to investigate the effect of mobilization and the type of liquid drink (drinking water or apple juice) on gastric emptying time among pediatric patients scheduled for elective surgery.

  Baseline and after clear fluid intake at 10, 15, 30, 60, and 90 minutes

Study Arms (4)

Group WM (Water+mobilization)

OTHER

All patients were randomized according to a table created on a computer using the closed-envelope method.Patients in the WM group (water+mobilization) were given water and mobilized

Other: group WM

Group WR(water+rest)

OTHER

All patients were randomized according to a table created on a computer using the closed-envelope method. Patients in the WR group (water+rest) were given water and stay in rest

Other: group WR

Group AR(apple juice+rest)

OTHER

All patients were randomized according to a table created on a computer using the closed-envelope method. Patients in the AR group (apple juice+rest) were given apple juice and stay in rest

Other: Group AR

Group AM (apple juice+mobilization)

OTHER

All patients were randomized according to a table created on a computer using the closed-envelope method. Patients in the AM group (apple juice+mobilization) were given water and mobilized

Other: Group AM

Interventions

group WM OTHER

Patients were given 5ml/kg dose of water and patients were mobilized.

Group WM (Water+mobilization)

group WR OTHER

Patients were given 5ml/kg dose of water and patients were rest.

Group WR(water+rest)

Group AR OTHER

Patients were given 5ml/kg dose of apple juice and patients were rest.

Group AR(apple juice+rest)

Group AM OTHER

Patients were given 5ml/kg dose of apple juice and patients were mobilized.

Group AM (apple juice+mobilization)

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA class I-III patients aged 4-11 years who were scheduled for elective urogenital surgery were included in the study.

You may not qualify if:

• Patients with pathology that prevents emptying in the upper gastrointestinal system, who have motility disorders in the gastrointestinal system, who are under follow-up due to diabetes mellitus (DM), who can not cooperate, who refuse to drink fluids or USG, who do not give consent from their families, who have a history of the lower esophagus or gastric operation, with a history of upper gastrointestinal bleeding in the last one month, clinically significant hepatic or renal failure, and a BMI \> 35 kg m2 were excluded from the study.

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Bursa Uludag University

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Seda Cansabuncu

  BURSA ULUDAG UNIVERSITY HOSPITAL

  PRINCIPAL INVESTIGATOR

• Selcan Akesen

  BURSA ULUDAG UNIVERSITY HOSPITAL

  STUDY CHAIR

• Belgin Yavaşcaoğlu

  BURSA ULUDAG UNIVERSITY HOSPITAL

  STUDY CHAIR

• Fatih Çelik

  BURSA ULUDAG UNIVERSITY HOSPITAL

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: August 8, 2023
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: August 8, 2023

Record last verified: 2023-07

Locations

TU (1)