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Postoperative Nausea and VomitingNCT06689046

Nausea and Vomiting Following Esophagogastroduodenoscopy: Prevalence and Predictive Factors

An observational study of Postoperative Nausea and Vomiting and Esophagogastroduodenoscopy, run by Ankara 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

Endoscopic procedures are widely implemented to diagnose both malignant and benign diseases. Nausea and vomiting is a common complication after anesthesia. Yet, nausea and vomiting after endoscopic procedures are not dully established. Read more about this study

Who is it for?
Any age
How many people
152 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2023to 1 Nov 2024
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients who had undergone an endoscopic procedure with sedation

Who may be able to join

  • having an endoscopic procedure with sedation

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Aksaray University

    Aksaray, 06110

Other trials in Turkey (Türkiye)

About this study

Endoscopic procedures are widely implemented to diagnose both malignant and benign diseases. Nausea and vomiting is a common complication after anesthesia. Yet, nausea and vomiting after endoscopic procedures are not dully established.

The primary aim of the study is to assess the incidence of postoperative nausea and vomiting in patients who underwent esophagogastroduodenoscopy. The secondary aim is to identify possible risk factors, both related to the patients and the procedure itself.

Read the detailed description

Nausea, vomiting, and retching are common issues that can complicate recovery after anesthesia. Many patients regard these experiences as unpleasant and reduce the quality of life and quality of recovery of patients. It has been suggested to increase healthcare costs due to prolonged length of stay, readmissions, and possibly life-threatening adverse effects such as pulmonary aspiration and aspiration pneumonia [1-3]. These unwanted consequences make postoperative nausea and vomiting (PONV) one of the most important issues for anesthesiologists.

PONV typically resolves on its own or can be effectively treated without lasting effects. Many studies have been carried out to identify prevalence and risk factors [4, 5]. The occurrence of PONV can vary depending on surgery, anesthesia, and patient characteristics. Generally, about 30% of patients undergoing surgery experience PONV, but this rate can rise to as high as 80% in high-risk patients [6].

Numerous studies are focused on evaluating various measures aimed at reducing the prevalence, severity, and duration of nausea and vomiting throughout the perioperative period [7]. Apfel score is a simple, widely accepted tool to asses patients' PONV risk which consists of four independent risk factors such as non-smoker, female gender, history of PONV, history of motion sickness, and opioid usage in the postoperative period [8]. Koivuranta risk score, which is similar to the Apfel score, also includes age and duration of surgery [9]. Procedure-related risk factors are suggested to play a role in PONV. PONV is more common following laparoscopic, bariatric, and gynecological surgeries and cholecystectomies. Longer surgery duration, and using volatile agents and opioids are also related to PONV [10].

Nausea and vomiting can occur after gastrointestinal endoscopic procedures due to the excessive stretching of the stomach and intestinal loops [11]. Wu et al. suggested that the rates of nausea and vomiting after endoscopic procedures were 4.1% and 2.9%, respectively. Wu and colleagues also observed that the female gender is an independent risk factor for developing PONV [12]. Hormati et al. established that 1.42% of patients reported experiencing nausea and vomiting following various gastrointestinal endoscopic procedures [13]. They noted that postoperative nausea and vomiting (PONV) was the second most common complication, following hemodynamic instability. Although endoscopic procedures are frequently performed around the globe, and also PONV is a common and possibly dangerous complication, the frequency and risk factors of developing PONV after endoscopic procedures have not been fully determined. The primary aim of the study is to assess the incidence of postoperative nausea and vomiting in patients who underwent esophagogastroduodenoscopy. An additional goal is to identify possible risk factors, both related to the patients and the procedure itself.

Keywords
postoperative nausea and vomiting, esophagogastroduodenoscopy
Medical subject headings
Postoperative Nausea and Vomiting

What is being measured

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

  1. Prevalence of Nausea and Vomiting following Esophagogastroduodenoscopy

    Prevalence of Nausea and Vomiting following Esophagogastroduodenoscopy

    Measured: post procedure day 1

Secondary outcomes (1)
  1. Risk Factors of Nausea and Vomiting following Esophagogastroduodenoscopy

    Risk Factors of Nausea and Vomiting following Esophagogastroduodenoscopy

    Measured: post procedure day 1

Timeline

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

  1. First posted14 Nov 2024
  2. Study start1 Nov 2023
  3. Primary completion1 Mar 2024
  4. Study completion1 Nov 2024

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
Retrospective
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06689046
Sponsor's protocol ID
2023/23-37
Status last verified
Nov 2024
First submitted
10 Nov 2024
Last updated
14 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Parra-Sanchez I, Abdallah R, You J, Fu AZ, Grady M, Cummings K 3rd, Apfel C, Sessler DI. A time-motion economic analysis of postoperative nausea and vomiting in ambulatory surgery. Can J Anaesth. 2012 Apr;59(4):366-75. doi: 10.1007/s12630-011-9660-x. Epub 2012 Jan 6.

    PubMed 22223185

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Nausea and Vomiting and Esophagogastroduodenoscopy, run by Ankara 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 14 Nov 2024. 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?

Prevalence of Nausea and Vomiting following Esophagogastroduodenoscopy (time frame: post procedure day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06689046, which also lists 1 linked publication.

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 14 Nov 2024.

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