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).
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
- Conditions the study is for
- Postoperative Nausea and Vomiting, Esophagogastroduodenoscopy
- 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.
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.
Prevalence of Nausea and Vomiting following Esophagogastroduodenoscopy
Prevalence of Nausea and Vomiting following Esophagogastroduodenoscopy
Measured: post procedure day 1
Secondary outcomes (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.
- First posted14 Nov 2024
- Study start1 Nov 2023
- Primary completion1 Mar 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülencan Yumuşak Ergin, Aksaray University Training and Research Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nausea and Vomiting Following Esophagogastroduodenoscopy: Prevalence and Predictive Factors
- ClinicalTrials.gov ID
- NCT06689046
- Acronym / sponsor ID
- 2023/23-37
- Keywords
- postoperative nausea and vomiting, esophagogastroduodenoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 14 Nov 2024 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who had undergone an endoscopic procedure with sedation
Key inclusion criteria (1 listed)
- having an endoscopic procedure with sedation
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Nausea and Vomiting following Esophagogastroduodenoscopy
Time frame: post procedure day 1
Prevalence of Nausea and Vomiting following Esophagogastroduodenoscopy
1 secondary outcome
Risk Factors of Nausea and Vomiting following Esophagogastroduodenoscopy
Time frame: post procedure day 1
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 14 Nov 2024.
- Background: PubMed 22223185Parra-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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.