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Postoperative Nausea and VomitingPGV-PONVNCT07916077

Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases

An observational study of Postoperative Nausea and Vomiting, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Postoperative nausea and vomiting (PONV) is one of the common complications in the pediatric patient group. Laparoscopic surgeries further increase the risk of postoperative nausea and vomiting due to increased intra-abdominal pressure and carbon dioxide use. Read more about this study

Who is it for?
Ages 3 to 12 years
Conditions the study is for
Postoperative Nausea and Vomiting
How many people
118 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Nov 2026to 15 May 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 3 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Children aged 3-12 years with American Society of Anesthesiologists (ASA) physical status I-III who undergo laparoscopic appendectomy at Etlik City Hospital

Who may be able to join

  • Children scheduled to undergo laparoscopic appendectomy
  • Age 3-12 years
  • ASA physical status I-III

Who cannot join

  • Previous gastrointestinal surgery
  • History of any gastrointestinal disease
  • History of motion sickness or postoperative nausea and vomiting
  • Use of medication with antiemetic effects
  • Developmental or neurological disorders
  • Parent or legal guradian unwilling to provide informed consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bikem Kösem contact

905380364066

bkosem95@gmail.com

Turkey (Türkiye)1 site
  • Etlik City Hospital

    Ankara, Ankara, 06000

    Bikem Kösem Canpolat, MD, 905380364066, bkosem95@gmail.com

    Bikem Kösem Canpolat, MD

Other trials in Turkey (Türkiye)

About this study

Official title: RELATIONSHIP BETWEEN PREOPERATIVE GASTRIC VOLUME AND POSTOPERATIVE NAUSEA AND VOMITING IN PEDIATRIC LAPAROSCOPIC APPENDECTOMY CASES

Postoperative nausea and vomiting (PONV) is one of the common complications in the pediatric patient group. Laparoscopic surgeries further increase the risk of postoperative nausea and vomiting due to increased intra-abdominal pressure and carbon dioxide use. In this study, gastric volume will be measured by ultrasonography in the preoperative period in order to investigate whether the fullness of the stomach and gastric volume are related to the predictability of postoperative nausea and vomiting. This study may contribute to clinical practices in predicting postoperative nausea and vomiting and developing preventive strategies in children aged 3-12 years undergoing laparoscopic appendectomy.

Read the detailed description

Postoperative nausea and vomiting is one of the complications frequently encountered in pediatric patients that seriously affects patient comfort. In the literature, the incidence of postoperative nausea and vomiting in the pediatric population is reported to be between 20-50%. This situation reduces patient satisfaction and prolongs discharge times.

Aspiration of stomach contents into the lungs, although its frequency varies in children, is seen between 0.02-0.1% in elective surgeries and can result in severe situations such as the need for mechanical ventilation and hypoxia. Although many factors have been investigated to evaluate the risk of aspiration and predict postoperative nausea and vomiting, the role of gastric volume, which is a physiological parameter, in this regard has not been sufficiently elucidated. A limited number of studies in adults have found a significant relationship between preoperative increased stomach volume and postoperative nausea and vomiting. However, there is not enough data examining this relationship in the pediatric age group. This study aims to contribute to the literature, to determine patients at risk of postoperative nausea and vomiting by measuring preoperative stomach volumes, and to develop preventive strategies. The case group in this study; There will be ASA I, II, III children between the ages of 3-12 who will undergo laparoscopic appendectomy surgery performed by the Pediatric Surgery unit in the Pediatric Operating Room. As a result of the power analysis performed using the G*Power 3.1.9.7 program, a total of at least 118 samples was found to be sufficient with 95% power and 5% margin of error (n1=59- n2=59). The study included the pediatric age group. For this reason, informed consent will be obtained from the family or legal representatives and verbal information will be given to the children appropriate to their age. Patients' age, gender, comorbidities, regular medications, height, weight, fasting period before anesthesia, history of motion sickness Patients will be evaluated in terms of nausea and vomiting, including ASA score, preoperative gastric volume, intraoperative heart rate every 15 minutes, blood pressure, saturation, end-tidal carbon dioxide value, intra-abdominal pressure value applied during laparoscopy, in the postoperative recovery room (0th hour), 6th and 24th hours. The identity information of the participants in this research will not be included in the report, thesis or scientific publication. All individuals will be identified anonymously in the study and each participant will be assigned a code number. History of previous gastrointestinal surgery, any history of gastrointestinal system disease, those with developmental or neurological disorders, those with a history of motion sickness or postoperative nausea and vomiting, those with preoperative antiemetic use, and those whose families do not give consent will not be included in the study.

Keywords
Preoperative gastric volume, Gastric ultrasonography, Pediatric anesthesia, Laparoscopic appendectomy, Postoperative nausea and vomiting
Medical subject headings
Postoperative Nausea and Vomiting

What participants receive

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

Study groups in NCT07916077
Study groupRoleWhat they receive
PONV GroupChildren aged 3-12 years with ASA I-III status undergoing laparoscopic appendectomy who develop postoperative nausea and vomiting during the first 24 hours after surgery. Assessments will be performed at 0, 6 and 24 hours postoperatively. Preoperative gastric volume will be estimated using ultrasonography.
Non-PONV GroupChildren aged 3-12 years with ASA I-III status undergoing laparoscopic appendectomy who do not develop postoperative nausea and vomiting during the first 24 hours after surgery. Assessments will be performed at 0, 6 and 24 hours postoperatively. Preoperative gastric volume will be estimated using ultrasonography.

What is being measured

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

  1. Presence of postoperative nausea and/or vomiting within 24 hours after surgery

    Presence of postoperative nausea and/or vomiting within 24 hours after surgery. Nausea will be assessed using child or parent reports. Vomiting will be defined as the observed expulsion of gastric contents.

    Measured: From the end of the surgery through 24 hours postoperatively.

Secondary outcomes (1)
  1. Preoperative gastric volume

    The relationship of the following variables with postoperative nausea and vomiting (PONV) was examined: gastric volume (ml) measured via preoperative ultrasonography; gastric volume normalized per kilogram of body weight (ml/kg); the frequency of nausea and vomiting episodes in patients who developed PONV; the need for antiemetic administration due to PONV; the qualitative assessment of preoperative gastric content (empty, liquid, or solid); the duration and feasibility of measuring gastric volume using ultrasonography; as well as the duration of anesthesia, duration of surgery, dosage of opioids administered, age, and gender.

    Measured: Preoperative measurement; PONV status determined during the first 24 hours after surgery.

Timeline

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

  1. First posted4 Nov 2026
  2. Study start15 Nov 2026 (estimated)
  3. Primary completion15 Apr 2027 (estimated)
  4. Study completion15 May 2027 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
118 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07916077
Sponsor's protocol ID
AEŞH-EK-2025-239
Acronym
PGV-PONV
Status last verified
Oct 2026
First submitted
29 Oct 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Nausea and Vomiting, run by Ankara Etlik City Hospital 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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 4 Nov 2026. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Bikem Kösem (905380364066, bkosem95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of postoperative nausea and/or vomiting within 24 hours after surgery (time frame: From the end of the surgery through 24 hours postoperatively.). 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 4 Nov 2026.

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