Post-operative Nausea and VomitingPhase 4NCT03297021
Effects of Ondansetron Dose and Timing on Post-operative Nausea and Vomiting
A Phase 4 study testing Ondansetron 4 MG and Ondansetron 8mg in people with Post-operative Nausea and Vomiting, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The aim is to evaluate the effectiveness of three different regimens of prophylactic ondansetron on the incidence and severity of post-operative nausea and vomiting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Nausea and Vomiting
- What is being tested?
- Ondansetron 4 MG and Ondansetron 8mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2017to 5 Apr 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I, II, III presenting for ambulatory surgery to be performed under general anesthesia
Who cannot join
- Patients with allergies or contraindications to study medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Effects of Ondansetron Dose and Timing on Rates of Post-operative Nausea and Vomiting
The aim is to evaluate the effectiveness of three different regimens of prophylactic ondansetron on the incidence and severity of post-operative nausea and vomiting.
Read the detailed description
Patients will be randomize to one of three arms: 4mg ondansetron pre-emergence, 8 mg ondansetron pre-emergence, or 4mg ondansetron pre-incision followed by 4mg ondansetron pre-emergence. Primary outcome will be incidence of PONV in the PACU prior to discharge.
- Conditions
- Post-operative Nausea and Vomiting
- Being tested
- Ondansetron 4 MG, Ondansetron 8mg
- Keywords
- ambulatory surgery, post-operative nausea and vomiting, general anesthesia
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron 4 MGDrug
dose as per arm selection
Ondansetron 8mgDrug
dose as per arm selection
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron 4mg Pre-emergence | Placebo comparator | Not described Receives: Drug: Ondansetron 4 MG |
| Ondansetron 8mg Pre-emergence | Experimental | Not described Receives: Drug: Ondansetron 8mg |
| Ondansetron Pre-Incision and Pre-emergence | Experimental | 4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence Receives: Drug: Ondansetron 4 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nausea Scale
Nausea Scale - full scale from 1-10, with higher score indicating more symptom of nausea
Measured: average of 4 hours in PACU and POD1
Secondary outcomes (4)
Number of Participants With Episodes of Vomiting in the PACU
Number of participants with episodes of vomiting in the Post Anesthesia Care Unit
Measured: average of 4 hours
Number of Participants With Symptoms on POD 1
Number of participants with symptom presence of nausea or vomiting or headache on post-operative day one
Measured: Day 1
Number of Participants Who Needed Rescue Anti-emetics
Number participants who needed rescue anti-emetics, i.e,, additional treatments needed to control nausea or vomiting in the PACU
Measured: average of 4 hours
Total Anesthesia Time
Measured: intraoperative, up to 3.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start23 Oct 2017
- Primary completion5 Apr 2019
- Study completion5 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-operative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Katz, Icahn School of Medicine at Mount Sinai
- Investigators
- Daniel Katz, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297021
- Sponsor's protocol ID
- GCO 17-1618
- Status last verified
- Jul 2020
- First submitted
- 26 Sep 2017
- Last updated
- 20 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ondansetron Dose and Timing on Rates of Post-operative Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT03297021
- Acronym / sponsor ID
- GCO 17-1618
- Conditions
- Post-operative Nausea and Vomiting
- Keywords
- ambulatory surgery, post-operative nausea and vomiting, general anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 29 Sep 2017 (actual)
- Results
- Posted 20 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim is to evaluate the effectiveness of three different regimens of prophylactic ondansetron on the incidence and severity of post-operative nausea and vomiting.
Detailed description
Patients will be randomize to one of three arms: 4mg ondansetron pre-emergence, 8 mg ondansetron pre-emergence, or 4mg ondansetron pre-incision followed by 4mg ondansetron pre-emergence. Primary outcome will be incidence of PONV in the PACU prior to discharge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ondansetron 4mg Pre-emergence | Placebo comparator | Drug: Ondansetron 4 MG |
| Ondansetron 8mg Pre-emergence | Experimental | Drug: Ondansetron 8mg |
| Ondansetron Pre-Incision and Pre-emergence | Experimental | Drug: Ondansetron 4 MG4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I, II, III presenting for ambulatory surgery to be performed under general anesthesia
Key exclusion criteria (1 listed)
- Patients with allergies or contraindications to study medications
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 |
|---|---|---|
| Ondansetron 4 MGdose as per arm selection | Drug | Ondansetron 4mg Pre-emergence, Ondansetron Pre-Incision and Pre-emergence |
| Ondansetron 8mgdose as per arm selection | Drug | Ondansetron 8mg Pre-emergence |
Primary outcome
Nausea Scale
Time frame: average of 4 hours in PACU and POD1
Nausea Scale - full scale from 1-10, with higher score indicating more symptom of nausea
4 secondary outcomes
Number of Participants With Episodes of Vomiting in the PACU
Time frame: average of 4 hours
Number of Participants With Symptoms on POD 1
Time frame: Day 1
Number of Participants Who Needed Rescue Anti-emetics
Time frame: average of 4 hours
Total Anesthesia Time
Time frame: intraoperative, up to 3.5 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Daniel Katz, MD principal investigator
Icahn School of Medicine at Mount Sinai
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 Ondansetron 4 MG and Ondansetron 8mg in people with Post-operative Nausea and Vomiting, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 20 Jul 2020. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 20 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Nausea Scale (time frame: average of 4 hours in PACU and POD1). 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 20 Jul 2020.