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).
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.
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Group AM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted8 Aug 2023
- Study start1 Jan 2021
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Cansabuncu, Uludag University
- Investigators
- Seda Cansabuncu, Principal investigator, BURSA ULUDAG UNIVERSITY HOSPITALSelcan Akesen, Study chair, BURSA ULUDAG UNIVERSITY HOSPITALBelgin Yavaşcaoğlu, Study chair, BURSA ULUDAG UNIVERSITY HOSPITALFatih Çelik, Study chair, BURSA ULUDAG UNIVERSITY HOSPITAL
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Mobilization on Gastric Emptying Time Among Pediatric Patients Scheduled for Elective Surgery: Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05981638
- Acronym / sponsor ID
- 2021-7/26
- Conditions
- Anesthesia, Fasting
- Keywords
- diagnostic imaging, fasting, anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group WM (Water+mobilization) | Other | Other: group WMAll 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 |
| Group WR(water+rest) | Other | Other: group WRAll 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 |
| Group AR(apple juice+rest) | Other | Other: Group ARAll 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 |
| Group AM (apple juice+mobilization) | Other | Other: Group AMAll 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 |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ASA class I-III patients aged 4-11 years who were scheduled for elective urogenital surgery were included in the study.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| group WMPatients were given 5ml/kg dose of water and patients were mobilized. | Other | Group WM (Water+mobilization) |
| group WRPatients were given 5ml/kg dose of water and patients were rest. | Other | Group WR(water+rest) |
| Group ARPatients were given 5ml/kg dose of apple juice and patients were rest. | Other | Group AR(apple juice+rest) |
| Group AMPatients were given 5ml/kg dose of apple juice and patients were mobilized. | Other | Group AM (apple juice+mobilization) |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seda Cansabuncu principal investigator
BURSA ULUDAG UNIVERSITY HOSPITAL
Selcan Akesen study chair
BURSA ULUDAG UNIVERSITY HOSPITAL
Belgin Yavaşcaoğlu study chair
BURSA ULUDAG UNIVERSITY HOSPITAL
1 site in 1 country: see every site and its status.
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.