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AnesthesiaNCT05981638

The Effect of Mobilization on Gastric Emptying Time

A study testing group WM, group WR and Group AR in people with Anesthesia and Fasting, run by Uludag University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 4 to 11 years
Conditions the study is for
Anesthesia, Fasting
What is being tested?
group WM, group WR and Group AR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2021to 1 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bursa Uludag University

    Bursa

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effect of Mobilization on Gastric Emptying Time Among Pediatric Patients Scheduled for Elective Surgery: Randomised Controlled Trial

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.

Read the detailed description

This prospective study was carried out at Bursa Uludag University Hospital between January 2021 and January 2022, following the approval of the local ethical committee (2021-7/26). Eighty-four ASA class I-III patients aged 4-11 years who were scheduled for elective urogenital surgery were included in the study. The parents were informed about the research, both verbally and in writing, and their consent was obtained. Patients with a 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, refuse to drink fluids or USG, do not provide consent from their families, have a history of lower esophagus or gastric operation, have a history of upper gastrointestinal bleeding in the last month, clinically significant hepatic or renal failure, and a BMI > 35 kg m2 were excluded from the study.During the preoperative visit, the child's physical characteristics (sex, age, weight, height, and body mass index) and initial vital parameters (heart rate and noninvasive blood presure) were recorded. Oral intake was discontinued in all children according to our common protocol (two hours for clear liquids; six hours for semi-solid and solid foods)All patients were randomized according to a table created on a computer using the closed-envelope method. It was planned such that only the surgeons knew which group the randomized patients were in. The anesthesiologist who performed the USG measurements did would not know which group the patient belonged to. Informed consent was obtained after the study protocol was properly explained to the children in accordance with their parents and age. In the clinic, clear liquids (water or apple juice) at room temperature (22°C) were administered to the patients by a second anesthesiologist and clinic nurse, in accordance with the group. The gastric antral area (GAA) was measured with USG just before the intake of liquid (T0), at the 5th minute (T5), 10th minute (T10), 30th minute (T30), 60th minute (T60), 90th minute (T90) by the anesthesiologist. This planned procedure was performed on the morning of the day of the operation, at least two hours before the induction of anesthesiaThe patients were grouped according to the kind of liquid (water or apple juice) and physical activity (resting or mobilization). [Group WR [water+rest (n:19)], Group WM [water+mobilization (n:21)], Group AR [apple juice (49.6kcal/100 ml + rest (n:23)] and Group AM [apple juice (49.6kcal/100 ml) + mobilization (n:21)]]. All the clear liquids were administered at a dose of 5 ml/kg. Patients in the resting groups (WR and AR); sat between ultrasound examinations and watched the age-appropriate animation of their choice. Age-appropriate audiovisual interventions such as cartoons and interactive games are effective in reducing preoperative anxiety in children. However, the selection of audiovisual interventions according to the age of the child is crucial. Patients in the mobilized group (WM and AM) were encouraged to walk into the clinic and their rooms between the ultrasound examinations.During USG imaging, patients were placed in a 45° semi-recumbent, right lateral decubitus (RLD) position. A portable ultrasound device (Logic E® GE, Boston, MA, USA) equipped with a high-frequency linear array transducer (probe 8-12 MHz) was used to obtain a cross-sectional image of the gastric antrum. The gastric antrum was identified in the sagittal or sagittal oblique plane in the epigastrium, along the edge of the left lobe of the liver, and anterior to either the aorta or the inferior vena cava, according to the standard protocol. Gastric emptying is influenced by gravity and should be faster in an upright positionGAA, craniocaudal (D1) (cm) and anteroposterior (D2) (cm) of the antrum, including stomach wall, in the RLD position werw calculated using real-time USG (Logic E® GE, Boston, USA) linear probe (8-12 MHz) diameters. A single cross-section of the antrum was obtained in the sagittal plane containing the left lobe of the liver and the aorta or inferior vena cava and was considered a standard level for measuring craniocaudal and anteroposterior diameters. The values of these diameters were inserted into the formula below to calculate the antral GAA, which correlates with gastric volume (GAA = π × D1 × D2/4).

A single investigator evaluated the hunger and thirst ratings of all children before drinking the beverages (0 min), and at 10, 15, 30, 60, and 90 min after drinking.

Conditions
Anesthesia, Fasting
Being tested
group WM, group WR, Group AR, Group AM
Keywords
diagnostic imaging, fasting, anesthesia
Medical subject headings
Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • group WMOther

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

  • group WROther

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

  • Group AROther

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

  • Group AMOther

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

Study groups in NCT05981638
Study groupRoleWhat they receive
Group WM (Water+mobilization)OtherAll 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
Receives: Other: group WM
Group WR(water+rest)OtherAll 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
Receives: Other: group WR
Group AR(apple juice+rest)OtherAll 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
Receives: Other: Group AR
Group AM (apple juice+mobilization)OtherAll 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
Receives: Other: Group AM

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2023
  2. Study start1 Jan 2021
  3. Primary completion1 Jan 2022
  4. Study completion1 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05981638
Sponsor's protocol ID
2021-7/26
Status last verified
Jul 2023
First submitted
8 Jun 2023
Last updated
8 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing group WM, group WR and Group AR in people with Anesthesia and Fasting, run by Uludag University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of gastric antral area change with USG within 90 minutes after clear fluid intake (time frame: Baseline and after clear fluid intake at 10, 15, 30, 60, and 90 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.

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