PONVPhase 4PONVNCT02468323
Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for Cesarean Sections Under Regional Anesthesia
A Phase 4 study testing Ondansetron and Palonosetron in people with PONV, run by Hospital de Base at 1 site in Brazil.
Trial summary
This study aims to compare the quality of perioperative antiemesis of palonosetron and ondansetron in patients undergoing cesarean section Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- PONV
- What is being tested?
- Ondansetron and Palonosetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2015to Feb 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists class I or II
- Scheduled for cesarean section on Maternal and Child Hospital of Brasilia, Federal District, Brazil
Who cannot join
- patients who had received antiemetics, diabetic, allergic to any study drug, corticosteroid use, psychoactive drugs, patients with vomiting in the course of gastrointestinal disease, eclampsia, heart disease, smokers, any evidence of fetal distress, psychiatric disease or who refused to participate.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Base do Distrito Federal
Brasília, Federal District, 70680250
About this study
Official title: Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for Cesarean Sections Under Regional Anesthesia: Study Single Center, Prospective, Double-blind, Randomized, Placebo Controlled
This study aims to compare the quality of perioperative antiemesis of palonosetron and ondansetron in patients undergoing cesarean section
Read the detailed description
Perioperative nausea and vomiting (PONV) related to spinal block anesthesia are common events and unpleasant for pregnant women. Its incidence can reach 80% in high-risk patients, and remains high despite the emergence of new antiemetic drugs.
Episodes untreated can result in prolonged stay in post-anesthetic care unit (PACU) and rehospitalization which can result in significant increase in overall costs of health care.
The purpose of the prophylaxis of PONV is therefore decrease its incidence, the stress of the patient, improve the quality and safety of surgical procedure and reduce hospital costs.
Antagonists of the 5-hydroxytryptamine 3 subtype receptor have been widely used and effective against PONV due to its efficacy and a favorable side-effect profile. Palonosetron is a new and potent drug generation5 second-HT antagonist with improved profile that acts longer. Recent studies where it was compared to ondansetron and palonosetron in high-risk patients in head and neck surgery and laparoscopic surgery is disclosed palonosetron far superior to ondansetron especially 2-24 hours after surgery. But there are no studies on caesareans comparing the two drugs.
This prospective, randomized, double-blind, placebo controlled, was designed to evaluate the efficacy of palonosetron compared with ondansetron and placebo for the prevention of nausea and vomiting in patients undergoing cesarean delivery under spinal anesthesia.
- Conditions
- PONV
- Being tested
- Placebo, Ondansetron, Palonosetron
- Keywords
- PONV, Palonosetron, Ondansetron, Cesarean section
- 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.
PlaceboDrug
Also called Saline
Patients will receive regular spinal anesthesia
OndansetronDrug
Patients will receive slow intravenous injection of ondansetron 4 mg after cord clamping
PalonosetronDrug
Patients will receive slow intravenous infection of palonosetron 75 mcg after cord clamping
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Patients in placebo group will receive spinal anesthesia with bupivacaine and morphine and a slow intravenous injection of saline 0,9%. Receives: Drug: Ondansetron; Drug: Palonosetron |
| Ondansetron group | Experimental | Patients in placebo group will receive spinal anesthesia with bupivacaine and morphine and a slow intravenous injection of ondansetron after cord clamping. Receives: Drug: Placebo; Drug: Palonosetron |
| Palonosetron group | Experimental | Patients in placebo group will receive spinal anesthesia with bupivacaine and morphine and a slow intravenous injection of palonosetron after cord clamping. Receives: Drug: Placebo; Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with nausea and vomiting
Measured: Within the first 48 hours after surgery
Secondary outcomes (6)
Nausea Scores on the Number Rating Scale
Quantify nausea by Number Rating Scale (NRS, ranging from 0 to 10 cm, zero being found when the patient is no nausea and ten, with maximum or un bearable nausea
Measured: Within the first 48 hours after surgery
Nausea Scores on the Verbal Rating Scale
Verbal Rating Scale (VRS), consisting of a list of phrases (no nausea, mild nausea, moderate nausea, intense nausea, maximum nausea)
Measured: Within the first 48 hours after surgery
Apgar Newborn
The resulting Apgar score ranges from zero to 10, measured at first and fifth minute
Measured: delivery
Likert Scale
Overall satisfaction with the nausea - vomiting experience in a Likert scale of four points (dissatisfied, neutral, satisfied and very satisfied)
Measured: 48 hours after surgery
Number of participants with adverse events as a measure of safety and tolerability
Intraoperative hemodynamic stability analysis through the incidence of tachycardia, hypertension, bradycardia, hypotension and consumed vasopressors
Measured: delivery
Number of participants with adverse events as a measure of safety and tolerability
Incidence of adverse effects such as nausea, vomiting, pruritus, urinary retention, drowsiness and consumed rescue antiemetics
Measured: Within the first 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startOct 2015
- Primary completionFeb 2017
- Study completionFeb 2017
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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Base
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabricio Tavares Mendonca, Hospital de Base
- Investigators
- Fabricio T Mendonca, MD, TSA, Principal investigator, Hospital de Base do Distrito Federal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468323
- Sponsor's protocol ID
- Palonosetron01
- Acronym
- PONV
- Status last verified
- Mar 2017
- First submitted
- 7 Jun 2015
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chattopadhyay S, Goswami S. Palonosetron Versus Ramosetron Prophylaxis for Control of Postoperative Nausea and Vomiting after Cesarean Delivery under Spinal Anesthesia. J Obstet Gynaecol India. 2015 Feb;65(1):28-33. doi: 10.1007/s13224-014-0612-6. Epub 2014 Oct 7.
PubMed 25737619
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for Cesarean Sections Under Regional Anesthesia: Study Single Center, Prospective, Double-blind, Randomized, Placebo Controlled
- ClinicalTrials.gov ID
- NCT02468323
- Acronym / sponsor ID
- PONV / Palonosetron01
- Conditions
- PONV
- Keywords
- PONV, Palonosetron, Ondansetron, Cesarean section
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hospital de BaseUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 10 Jun 2015 (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.
This study aims to compare the quality of perioperative antiemesis of palonosetron and ondansetron in patients undergoing cesarean section
Detailed description
Perioperative nausea and vomiting (PONV) related to spinal block anesthesia are common events and unpleasant for pregnant women. Its incidence can reach 80% in high-risk patients, and remains high despite the emergence of new antiemetic drugs.
Episodes untreated can result in prolonged stay in post-anesthetic care unit (PACU) and rehospitalization which can result in significant increase in overall costs of health care.
The purpose of the prophylaxis of PONV is therefore decrease its incidence, the stress of the patient, improve the quality and safety of surgical procedure and reduce hospital costs.
Antagonists of the 5-hydroxytryptamine 3 subtype receptor have been widely used and effective against PONV due to its efficacy and a favorable side-effect profile. Palonosetron is a new and potent drug generation5 second-HT antagonist with improved profile that acts longer. Recent studies where it was compared to ondansetron and palonosetron in high-risk patients in head and neck surgery and laparoscopic surgery is disclosed palonosetron far superior to ondansetron especially 2-24 hours after surgery. But there are no studies on caesareans comparing the two drugs.
This prospective, randomized, double-blind, placebo controlled, was designed to evaluate the efficacy of palonosetron compared with ondansetron and placebo for the prevention of nausea and vomiting in patients undergoing cesarean delivery under spinal anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: Ondansetron, Drug: PalonosetronPatients in placebo group will receive spinal anesthesia with bupivacaine and morphine and a slow intravenous injection of saline 0,9%. |
| Ondansetron group | Experimental | Drug: Placebo, Drug: PalonosetronPatients in placebo group will receive spinal anesthesia with bupivacaine and morphine and a slow intravenous injection of ondansetron after cord clamping. |
| Palonosetron group | Experimental | Drug: Placebo, Drug: OndansetronPatients in placebo group will receive spinal anesthesia with bupivacaine and morphine and a slow intravenous injection of palonosetron after cord clamping. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists class I or II
- Scheduled for cesarean section on Maternal and Child Hospital of Brasilia, Federal District, Brazil
Key exclusion criteria (1 listed)
- patients who had received antiemetics, diabetic, allergic to any study drug, corticosteroid use, psychoactive drugs, patients with vomiting in the course of gastrointestinal disease, eclampsia, heart disease, smokers, any evidence of fetal distress, psychiatric disease or who refused to participate.
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 |
|---|---|---|
| PlaceboAlso: SalinePatients will receive regular spinal anesthesia | Drug | Ondansetron group, Palonosetron group |
| OndansetronPatients will receive slow intravenous injection of ondansetron 4 mg after cord clamping | Drug | Palonosetron group, Placebo group |
| PalonosetronPatients will receive slow intravenous infection of palonosetron 75 mcg after cord clamping | Drug | Ondansetron group, Placebo group |
Primary outcome
Number of participants with nausea and vomiting
Time frame: Within the first 48 hours after surgery
6 secondary outcomes
Nausea Scores on the Number Rating Scale
Time frame: Within the first 48 hours after surgery
Nausea Scores on the Verbal Rating Scale
Time frame: Within the first 48 hours after surgery
Apgar Newborn
Time frame: delivery
Likert Scale
Time frame: 48 hours after surgery
Number of participants with adverse events as a measure of safety and tolerability
Time frame: delivery
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Within the first 48 hours 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 9 Mar 2017.
- Background: PubMed 25737619Chattopadhyay S, Goswami S. Palonosetron Versus Ramosetron Prophylaxis for Control of Postoperative Nausea and Vomiting after Cesarean Delivery under Spinal Anesthesia. J Obstet Gynaecol India. 2015 Feb;65(1):28-33. doi: 10.1007/s13224-014-0612-6. Epub 2014 Oct 7.
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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.
Fabricio T Mendonca, MD, TSA principal investigator
Hospital de Base do Distrito Federal
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 and Palonosetron in people with PONV, run by Hospital de Base at 1 site in Brazil.
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 2 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 9 Mar 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 Brazil. 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?
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?
Number of participants with nausea and vomiting (time frame: Within the first 48 hours after surgery). 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 NCT02468323, 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 9 Mar 2017.