Postoperative Nausea and VomitingNCT05970055
Prevalence and Associated Factors of Post-operative Nausea and Vomiting
An observational study of Postoperative Nausea and Vomiting, run by Sara Timerga at 1 site in Ethiopia.
Trial summary
Postoperative nausea and vomiting (PONV) is a surgical complication defined as any nausea, and vomiting with in the first 24-48 hours after surgery in inpatients. Nausea is an unpleasant feeling or desire to vomit without expulsive muscular movement, while vomiting is a forceful expulsion or reflux of the gastric… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- elective surgery
- Type of treatment
- Surgery or procedure
- How many people
- 677 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Feb 2022to 30 Jul 2022
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: All adult, elective patients who underwent elective surgery under anesthesia at the Dessie comprehensive specialized hospital during the study period
Who may be able to join
- All adult patients, who underwent elective surgery under anesthesia in the study period.
Who cannot join
- Patients who didn't gain their consciousness postoperatively, patients who underwent emergency surgery, patients who were re-operated on during the study period, surgical patients medical illness that predispose them to nausea and vomiting, and patients discharged before 24 hours postoperatively
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Associated Factors of Post-operative Nausea and Vomiting Among Adult Patients Undergoing Elective Surgery in DCSH, Dessie, Northeast Ethiopia, 2022
Postoperative nausea and vomiting (PONV) is a surgical complication defined as any nausea, and vomiting with in the first 24-48 hours after surgery in inpatients. Nausea is an unpleasant feeling or desire to vomit without expulsive muscular movement, while vomiting is a forceful expulsion or reflux of the gastric contents through the mouth. Postoperative nausea and vomiting is one of the most common complication associated anesthesia and surgery. It is considered the most common cause of morbidity, and it has significant effects on patient satisfaction. In spite of recent development of anesthesia and surgical techniques, the incidence of PONV remains high. This common anesthetic and surgical side effect has been reported to increase patient dissatisfaction and can be just as distressing to patients as postoperative pain is.
Read the detailed description
Postoperative nausea and vomiting is caused by multiple factors; patient related, anesthesia and surgery related risk factors have been identified. Patient related factors include female gender post-puberty, nonsmoking status, history of PONV or motion sickness, and childhood after infancy and younger adulthood. Use of volatile anesthetics, nitrous oxide, large-dose neostigmine, or intraoperative or postoperative opioids are factors related to anesthesia, while the type of procedures like gynecologic, ophthalmological, ontological, thyroid surgery laparoscopic, abdominal surgery and duration of the procedure are some of surgery related risk factors.
The incidence of PONV for over multiple individual studies conducted around the world, has been estimated to be 25% to 30% and up to 80% in high risk groups. The incidence of PONV is estimated to range from 20%-36%.
Post-operative nausea and vomiting imposes multiple impacts on patients. The main one being a decrease satisfaction, but more importantly it leads to dehydration, electrolyte imbalance, aspiration of gastric secretions, esophageal rupture, bleeding, increased morbidity, and delayed discharge from hospital.
The study aimed to assess the incidence and associated factors of post-operative nausea and vomiting, which is believed to be a main contributing factor to dissatisfaction and delayed recovery seen in our country. The study was done from February to April 2022 in patients undergoing elective surgery at Dessie comprehensive specialized hospital, Ethiopia.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- elective surgery
- 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.
elective surgeryProcedure or surgery
All elective surgical procedures performed under the study period will be included.
| Study group | Role | What they receive |
|---|---|---|
| PONV and Non PONV | PONV- patients who developed nausea and vomiting postoperatively Non PONV- patients who did not develop nausea and vomiting postoperatively Receives: Procedure: elective surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative nausea and vomiting
Postoperative nausea and vomiting (PONV) is defined as any nausea, retching, or vomiting occurring during the first 24-48 h after surgery.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Feb 2022
- Primary completion30 Apr 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 677 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Timerga
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara Timerga, Wollo University
- Investigators
- Sara Timerga, Principal investigator, Wollo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970055
- Sponsor's protocol ID
- WolloU
- Status last verified
- Jul 2023
- First submitted
- 23 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan to share IPD will depend on the requests.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Associated Factors of Post-operative Nausea and Vomiting Among Adult Patients Undergoing Elective Surgery in DCSH, Dessie, Northeast Ethiopia, 2022
- ClinicalTrials.gov ID
- NCT05970055
- Acronym / sponsor ID
- WolloU
- Conditions
- Postoperative Nausea and Vomiting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 677 participants (actual)
- Lead sponsor
- Sara TimergaUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 1 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.
Postoperative nausea and vomiting (PONV) is a surgical complication defined as any nausea, and vomiting with in the first 24-48 hours after surgery in inpatients. Nausea is an unpleasant feeling or desire to vomit without expulsive muscular movement, while vomiting is a forceful expulsion or reflux of the gastric contents through the mouth. Postoperative nausea and vomiting is one of the most common complication associated anesthesia and surgery. It is considered the most common cause of morbidity, and it has significant effects on patient satisfaction. In spite of recent development of anesthesia and surgical techniques, the incidence of PONV remains high. This common anesthetic and surgical side effect has been reported to increase patient dissatisfaction and can be just as distressing to patients as postoperative pain is.
Detailed description
Postoperative nausea and vomiting is caused by multiple factors; patient related, anesthesia and surgery related risk factors have been identified. Patient related factors include female gender post-puberty, nonsmoking status, history of PONV or motion sickness, and childhood after infancy and younger adulthood. Use of volatile anesthetics, nitrous oxide, large-dose neostigmine, or intraoperative or postoperative opioids are factors related to anesthesia, while the type of procedures like gynecologic, ophthalmological, ontological, thyroid surgery laparoscopic, abdominal surgery and duration of the procedure are some of surgery related risk factors.
The incidence of PONV for over multiple individual studies conducted around the world, has been estimated to be 25% to 30% and up to 80% in high risk groups. The incidence of PONV is estimated to range from 20%-36%.
Post-operative nausea and vomiting imposes multiple impacts on patients. The main one being a decrease satisfaction, but more importantly it leads to dehydration, electrolyte imbalance, aspiration of gastric secretions, esophageal rupture, bleeding, increased morbidity, and delayed discharge from hospital.
The study aimed to assess the incidence and associated factors of post-operative nausea and vomiting, which is believed to be a main contributing factor to dissatisfaction and delayed recovery seen in our country. The study was done from February to April 2022 in patients undergoing elective surgery at Dessie comprehensive specialized hospital, Ethiopia.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PONV and Non PONV | – | Procedure: elective surgeryPONV- patients who developed nausea and vomiting postoperatively Non PONV- patients who did not develop nausea and vomiting postoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adult, elective patients who underwent elective surgery under anesthesia at the Dessie comprehensive specialized hospital during the study period
Key inclusion criteria (1 listed)
- All adult patients, who underwent elective surgery under anesthesia in the study period.
Key exclusion criteria (1 listed)
- Patients who didn't gain their consciousness postoperatively, patients who underwent emergency surgery, patients who were re-operated on during the study period, surgical patients medical illness that predispose them to nausea and vomiting, and patients discharged before 24 hours postoperatively
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 |
|---|---|---|
| elective surgeryAll elective surgical procedures performed under the study period will be included. | Procedure or surgery | PONV and Non PONV |
Primary outcome
post-operative nausea and vomiting
Time frame: 24 hours
Postoperative nausea and vomiting (PONV) is defined as any nausea, retching, or vomiting occurring during the first 24-48 h after 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 1 Aug 2023.
- Individual participant dataSharing planned: Undecided. The plan to share IPD will depend on the requests.
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A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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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.
Sara Timerga principal investigator
Wollo University
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, run by Sara Timerga at 1 site in Ethiopia.
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 1 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 Ethiopia. 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?
post-operative nausea and vomiting (time frame: 24 hours). 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 1 Aug 2023.