Postoperative NauseaPhase 4PONVNCT05632224
Postoperative Nausea and Vomiting in Laparoscopic Abdominal Surgery
A Phase 4 study testing Aprepitant and Granisetron in people with Postoperative Nausea and Vomiting, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare frequency with postoperative nausea and vomiting in ASA( American Society of Anesthesiologists) I, II patients undergoing laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea, Vomiting
- What is being tested?
- Aprepitant and Granisetron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Nov 2022to 31 Jan 2023
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I, II patients patients undergoing laparoscopic surgery
Who cannot join
- ASA III and above patients who refused to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University Ankara Hospital
Ankara
Nedim Çekmen, Professor;MD, +905307384682, nedimcekmen@yahoo.com
About this study
Official title: Retrospective Comparison of the Effects of Granisetron and Aprepitant in the Prevention of Postoperative Nausea and Vomiting in Laparoscopic Abdominal Surgery
The goal of this clinical trial is to compare frequency with postoperative nausea and vomiting in ASA( American Society of Anesthesiologists) I, II patients undergoing laparoscopic surgery.
The main question[s] it aims to answer are:
- Primary Outcome is the incidence of nausea and vomiting between 0-6 and 6-24 hours postoperatively and the need for additional antiemetics
- Secondary outcome is detection of additional analgesic needs and complications between 0-6 and 6-24 hours postoperatively.
Participants will receive aprepitant or granisetron for prevention of postoperative nausea and vomiting.
Read the detailed description
The aim of this study is to investigate the effectiveness of drugs used for postoperative nausea and vomiting in laparoscopic surgeries.
In the research; During the operation, the patient's vitals will be recorded intraoperative forms. Vitals are; heart rate, blood pressure, oxygen saturation, end tidal carbon dioxide levels; according to the pain level after awakening from the patient follow-up forms in the service.
The doses and times of analgesics will be screened, the frequencies of postoperative nausea, retching, vomiting, and additional antiemetic doses will be screened, respiratory depression, complications of anesthesia, arrhythmia, laryngospasm, hypo-hypertension, headache, dizziness, allergic reactions anxiety symptoms will be screened too.
we will try to emphasize which antiemetic is more effective than the other and which one has few side effects
- Conditions
- Postoperative Nausea, Vomiting
- Being tested
- Aprepitant, Granisetron
- Keywords
- postoperative nausea and vomiting, laparoscopic surgery
- Medical subject headings
- Postoperative Nausea and Vomiting, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprepitantDrug
Also called Emend
The drug is given 1 hour before the start of the surgery
GranisetronDrug
Also called Sinarex
The drug is given 10 minutes before the patients's extubation
| Study group | Role | What they receive |
|---|---|---|
| Aprepitant | Active comparator | Substance P inhibitor chemotherapeutic and also useable for prevention of postoperative nausea and vomiting Receives: Drug: Aprepitant |
| Granisetron | Active comparator | 5- HT3( 5-hydroksitriptamine 3) antagonist drug for prevention of postoperative nausea and vomiting Receives: Drug: Granisetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of nausea
the incidence of nausea between 0-6 and 6-24 hours postoperatively
Measured: postoperative 24 hours
the need for additional antiemetics
the need for additional antiemetics between 0-6 and 6-24 hours postoperatively
Measured: postoperative 24 hours
incidence of vomiting
the incidence of vomiting between 0-6 and 6-24 hours postoperatively
Measured: postoperative 24 hours
Secondary outcomes (2)
additional analgesic need
Detection of additional analgesic needs between 0-6 and 6-24 hours postoperatively.
Measured: postoperative 24 hours
detection of complications
detection of complications between 0-6 and 6-24 hours postoperatively.
Measured: postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start24 Nov 2022 (estimated)
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative NauseaStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- group 1:patient who receive aprepitant group 2: patient who receive granisetron
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Begüm Nemika Gökdemir, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632224
- Sponsor's protocol ID
- KA22/252
- Acronym
- PONV
- Status last verified
- Nov 2022
- First submitted
- 27 Oct 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Comparison of the Effects of Granisetron and Aprepitant in the Prevention of Postoperative Nausea and Vomiting in Laparoscopic Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05632224
- Acronym / sponsor ID
- PONV / KA22/252
- Conditions
- Postoperative Nausea, Vomiting
- Keywords
- postoperative nausea and vomiting, laparoscopic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 24 Nov 2022 (estimated)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 30 Nov 2022 (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.
The goal of this clinical trial is to compare frequency with postoperative nausea and vomiting in ASA( American Society of Anesthesiologists) I, II patients undergoing laparoscopic surgery.
The main question[s] it aims to answer are:
- Primary Outcome is the incidence of nausea and vomiting between 0-6 and 6-24 hours postoperatively and the need for additional antiemetics
- Secondary outcome is detection of additional analgesic needs and complications between 0-6 and 6-24 hours postoperatively.
Participants will receive aprepitant or granisetron for prevention of postoperative nausea and vomiting.
Detailed description
The aim of this study is to investigate the effectiveness of drugs used for postoperative nausea and vomiting in laparoscopic surgeries.
In the research; During the operation, the patient's vitals will be recorded intraoperative forms. Vitals are; heart rate, blood pressure, oxygen saturation, end tidal carbon dioxide levels; according to the pain level after awakening from the patient follow-up forms in the service.
The doses and times of analgesics will be screened, the frequencies of postoperative nausea, retching, vomiting, and additional antiemetic doses will be screened, respiratory depression, complications of anesthesia, arrhythmia, laryngospasm, hypo-hypertension, headache, dizziness, allergic reactions anxiety symptoms will be screened too.
we will try to emphasize which antiemetic is more effective than the other and which one has few side effects
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- group 1:patient who receive aprepitant group 2: patient who receive granisetron
| Arm | Type | Receives |
|---|---|---|
| Aprepitant | Active comparator | Drug: AprepitantSubstance P inhibitor chemotherapeutic and also useable for prevention of postoperative nausea and vomiting |
| Granisetron | Active comparator | Drug: Granisetron5- HT3( 5-hydroksitriptamine 3) antagonist drug for prevention of postoperative nausea and vomiting |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I, II patients patients undergoing laparoscopic surgery
Key exclusion criteria (1 listed)
- ASA III and above patients who refused to participate in 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 |
|---|---|---|
| AprepitantAlso: EmendThe drug is given 1 hour before the start of the surgery | Drug | Aprepitant |
| GranisetronAlso: SinarexThe drug is given 10 minutes before the patients's extubation | Drug | Granisetron |
Primary outcome
incidence of nausea
Time frame: postoperative 24 hours
the incidence of nausea between 0-6 and 6-24 hours postoperatively
the need for additional antiemetics
Time frame: postoperative 24 hours
the need for additional antiemetics between 0-6 and 6-24 hours postoperatively
incidence of vomiting
Time frame: postoperative 24 hours
the incidence of vomiting between 0-6 and 6-24 hours postoperatively
2 secondary outcomes
additional analgesic need
Time frame: postoperative 24 hours
detection of complications
Time frame: postoperative 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aprepitant and Granisetron in people with Postoperative Nausea and Vomiting, run by Baskent 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: status not confirmed, as of the sponsor's last update on 30 Nov 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Begüm Ne Gökdemir, MD (+905389598290, begokdemir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of nausea (time frame: postoperative 24 hours). The study lists 3 primary outcomes in all. 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 30 Nov 2022.