PONVPhase 4NCT02809378
The Effects of Anesthetic Techniques and Palonosetron Administration on the Incidence of PONV
A Phase 4 study testing Palonosetron, sevoflurane and remifentanil in people with PONV and Palonosetron, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
The incidence of postoperative nausea and vomiting (PONV) after thyroidectomy have been shown to be relatively high compared other surgeries, with a reported incidence 65-75 %. PONV may increase patient discomfort, delay patient discharge, and increase the cost of patient care, the risk of postoperative bleeding which… Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- PONV, Palonosetron, Anesthesia
- What is being tested?
- Palonosetron, sevoflurane and remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2016to 20 Apr 2017
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients undergoing thyroidectomy euthyroid status American Society of Anesthesiology Physical status 1,2
Who cannot join
- Ideal body weight >130% gastrointestinal disease prior administration of anti-emetics (24hr)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Anesthetic Techniques and Palonosetron Administration on the Incidence of Postoperative Nausea and Vomiting in the Women Patients Undergoing Thyroidectomy
The incidence of postoperative nausea and vomiting (PONV) after thyroidectomy have been shown to be relatively high compared other surgeries, with a reported incidence 65-75 %. PONV may increase patient discomfort, delay patient discharge, and increase the cost of patient care, the risk of postoperative bleeding which may potentially cause airway obstruction.
It is reported that the maintenance of anesthesia with propofol-remifentanil or sevoflurane-propofol-remifentanil decreased the incidence of PONV compared sevoflurane alone, but failed to demonstrate the decreased incidence of PONV in 6-24 hr postoperative period in patients undergoing thyroidectomy. Administration of Palonosetron, newly developed 5-HT3 antagonists with long half life (48 hrs) may decrease the incidence of PONV particularly during this period.
The purpose of this study was to evaluate and compare the incidence of PONV after thyroidectomy with three different anesthetic methods, sevoflurane or sevoflurane-propofol-remifentanil or sevoflurane-propofol-remifentanil-palonosetron in woman patients.
- Conditions
- PONV, Palonosetron, Anesthesia
- Being tested
- Palonosetron, sevoflurane, remifentanil, pentothal sodium, propofol
- 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.
PalonosetronDrug
newly developed 5-HT3 antagonists with long half life (48 hrs) intravenous administration prior to anesthesia induction
sevofluraneDrug
Inhalational anesthetics Halogenated.
remifentanilDrug
ultra-short acting opioid anesthetics
pentothal sodiumDrug
intra-venous anesthetics for anesthesia induction
propofolDrug
intra-venous anesthetics for anesthesia induction and maintenance
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Experimental | anesthesia induction with pentothal sodium (4-5 mg/kg), maintenance with sevoflurane(1.6-2.5 vol%) Receives: Drug: sevoflurane; Drug: pentothal sodium |
| sevoflurane, remifentanil, and propofol | Experimental | anesthesia induction and maintenance with remifentanil, propofol and sevoflurane(1.6-2.5 vol%) Receives: Drug: sevoflurane; Drug: remifentanil; Drug: propofol |
| Sevoflurane, remifentanil, propofol, and palonosetron | Experimental | anesthesia induction and maintenance with remifentanil, propofol and sevoflurane(1.6-2.5 vol%), and palonosetron 75 ug administration prior to anesthesia induction. Receives: Drug: Palonosetron; Drug: sevoflurane; Drug: remifentanil; Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative nausea and vomiting
Measured: 24 hour postoperative
Secondary outcomes (3)
incidence of postoperative nausea and vomiting
Measured: at immediate postoperative
incidence of postoperative nausea and vomiting
Measured: 6 hour postoperative
incidence of postoperative nausea and vomiting
Measured: 48 hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion20 Apr 2017
- Study completion20 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PONVStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- HK inno.N Corporation
- Responsible party
- Principal investigator, DAE HEE KIM, Ajou University School of Medicine
- Investigators
- Dae Hee Kim, MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809378
- Sponsor's protocol ID
- MED-CT4-15-461
- Status last verified
- Jul 2017
- First submitted
- 16 Jun 2016
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Anesthetic Techniques and Palonosetron Administration on the Incidence of Postoperative Nausea and Vomiting in the Women Patients Undergoing Thyroidectomy
- ClinicalTrials.gov ID
- NCT02809378
- Acronym / sponsor ID
- MED-CT4-15-461
- Conditions
- PONV, Palonosetron, Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Collaborators
- HK inno.N Corporation
- Study start
- Jun 2016
- Primary completion
- 20 Apr 2017 (actual)
- Study completion
- 20 Apr 2017 (actual)
- First posted
- 22 Jun 2016 (estimated)
- 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 incidence of postoperative nausea and vomiting (PONV) after thyroidectomy have been shown to be relatively high compared other surgeries, with a reported incidence 65-75 %. PONV may increase patient discomfort, delay patient discharge, and increase the cost of patient care, the risk of postoperative bleeding which may potentially cause airway obstruction.
It is reported that the maintenance of anesthesia with propofol-remifentanil or sevoflurane-propofol-remifentanil decreased the incidence of PONV compared sevoflurane alone, but failed to demonstrate the decreased incidence of PONV in 6-24 hr postoperative period in patients undergoing thyroidectomy. Administration of Palonosetron, newly developed 5-HT3 antagonists with long half life (48 hrs) may decrease the incidence of PONV particularly during this period.
The purpose of this study was to evaluate and compare the incidence of PONV after thyroidectomy with three different anesthetic methods, sevoflurane or sevoflurane-propofol-remifentanil or sevoflurane-propofol-remifentanil-palonosetron in woman patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Experimental | Drug: sevoflurane, Drug: pentothal sodiumanesthesia induction with pentothal sodium (4-5 mg/kg), maintenance with sevoflurane(1.6-2.5 vol%) |
| sevoflurane, remifentanil, and propofol | Experimental | Drug: sevoflurane, Drug: remifentanil, Drug: propofolanesthesia induction and maintenance with remifentanil, propofol and sevoflurane(1.6-2.5 vol%) |
| Sevoflurane, remifentanil, propofol, and palonosetron | Experimental | Drug: Palonosetron, Drug: sevoflurane, Drug: remifentanil, Drug: propofolanesthesia induction and maintenance with remifentanil, propofol and sevoflurane(1.6-2.5 vol%), and palonosetron 75 ug administration prior to anesthesia induction. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients undergoing thyroidectomy euthyroid status American Society of Anesthesiology Physical status 1,2
Key exclusion criteria (1 listed)
- Ideal body weight >130% gastrointestinal disease prior administration of anti-emetics (24hr)
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 |
|---|---|---|
| Palonosetronnewly developed 5-HT3 antagonists with long half life (48 hrs) intravenous administration prior to anesthesia induction | Drug | Sevoflurane, remifentanil, propofol, and palonosetron |
| sevofluraneInhalational anesthetics Halogenated. | Drug | Sevoflurane, Sevoflurane, remifentanil, propofol, and palonosetron, sevoflurane, remifentanil, and propofol |
| remifentanilultra-short acting opioid anesthetics | Drug | Sevoflurane, remifentanil, propofol, and palonosetron, sevoflurane, remifentanil, and propofol |
| pentothal sodiumintra-venous anesthetics for anesthesia induction | Drug | Sevoflurane |
| propofolintra-venous anesthetics for anesthesia induction and maintenance | Drug | Sevoflurane, remifentanil, propofol, and palonosetron, sevoflurane, remifentanil, and propofol |
Primary outcome
incidence of postoperative nausea and vomiting
Time frame: 24 hour postoperative
3 secondary outcomes
incidence of postoperative nausea and vomiting
Time frame: at immediate postoperative
incidence of postoperative nausea and vomiting
Time frame: 6 hour postoperative
incidence of postoperative nausea and vomiting
Time frame: 48 hour postoperative
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 21 Jul 2017.
- 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.
Dae Hee Kim, MD principal investigator
Ajou University School of Medicine
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 Palonosetron, sevoflurane and remifentanil in people with PONV and Palonosetron, run by Ajou University School of Medicine at 1 site in South Korea.
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 21 Jul 2017. 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 South Korea. 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?
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?
incidence of postoperative nausea and vomiting (time frame: 24 hour postoperative). 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 21 Jul 2017.