PONVPhase 4PONVNCT00952133
Efficacy of IV Palo With IV Dexamethasone vs IV Palo for Prevention of Immediate & Delayed PONV
A Phase 4 study testing Palonosetron only and Palonosetron with Dexamethasone in people with PONV, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to determine if subjects who receive Palonosetron plus Dexamethasone have less post-operative nausea and vomiting (PONV) than those who receive Palonosetron alone. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- PONV
- What is being tested?
- Palonosetron only and Palonosetron with Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Apr 2011
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Has signed an informed consent form
- Have an American Society of Anesthesiologists (ASA) Physical Status Classification of I, II, or III
- Female, 18-55 years old
- surgically sterilized, or
- pre-menopausal, with a negative pregnancy test within 7 days before study medication administration
- Male, 18-55 years old, who has more than 3 risk factors for PONV
Show all 11Show fewer
- Undergoing outpatient laparoscopic gynecological surgery or laparoscopic abdominal surgery, scheduled for between 1 and 3 hours duration
- Known to have a history of post-operative nausea and vomiting and/or a history of motion sickness
- Has been a non-smoker for at least the previous 12 consecutive months
- Is able and willing to complete a subject diary until the end of the 96 Hour Follow-Up Assessment period
- Will be available to respond to follow-up by study personnel at 72 and 96 hours post emergence from anesthesia
Who cannot join
- Has an ASA Physical Status Classification of IV or V
- Is pregnant or breastfeeding
- Has been taking more than 10-15mg of oxycodone, or an equivalent opioid dose, on a regular, daily basis, for more than 3 consecutive days before surgery
- Has received an investigational drug in the precious 30 days or who is schedule to receive any investigational drug during the study period
- Has persistent or recurrent nausea and/or vomiting due to other etiologies, including but not limited to, gastric outlet obstruction, hypercalcemia, active peptic ulcer, increased intracranial pressure, or brain metastases
- Experienced retching or vomiting or uncontrolled nausea within 48 hours before administration of study drug
Show all 17Show fewer
- Received medication with known or potential antiemetic activity within 24 hours before receiving study drug. This includes, but is not limited to: phenothiazines, butyrophenones, hydroxyzine, lorazepam, cannabinoids, metoclopramide, corticosteroids (with the exception of topical steroids for skin disorder and inhaled steroids for respiratory disorders), trimethobenzamide, monoamine oxidase inhibitors, lithium, and 5-HT3 receptor antagonists. Subjects who might require one or more of these medications during the 24-hour treatment period, other than as described in this protocol, are also excluded.
- Note: benzodiazepines other than lorazepam are allowed within 24 hours before and during study period, but only when used for indications such as anxiety or to induce sleep.
- Received radiation therapy to abdomen or pelvis in the 7 days prior to receiving study medication and/or will receive radiation therapy to abdomen or pelvis in the evaluation period.
- Has a history of poorly controlled diabetes mellitus
- Has a history of wound dehiscence
- Has had an incidence of necrotizing fasciitis, or any similar infectious process, within the previous 90 days
- Has a know systemic fungal infection, history of tuberculosis, or other mycobacterial infection
- Is immunocompromised - defined as a white blood cell (WBC) count of <3,000 mm3
- Has any current or past medical condition (e.g., vagotomy) and/or require medication to treat a condition that could confound the evaluation of the data collected in this clinical trail
- Has a known hypersensitivity or contraindication to palonosetron hydrochloride or any another 5-HT3 receptor antagonist, dexamethasone, or any scheduled anesthetic or analgesic agents
- Has a known hypersensitivity to fentanyl and/or ketorolac tromethamine
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center
New York, New York, 10016
About this study
Official title: Randomized Double Blind Study to Evaluate the Efficacy of IV Palo w/ IV Dexamethasone vs IV Palo for Prevention of Immediate & Delayed Post-Operative Nausea/Vomiting in Subj Undergoing Laparoscopic Surgeries w/a High Emetogenic Risk
The purpose of this study is to determine if subjects who receive Palonosetron plus Dexamethasone have less post-operative nausea and vomiting (PONV) than those who receive Palonosetron alone.
Read the detailed description
Post-operative nausea and vomiting (PONV) is a frequent complication of surgery, with considerable medical and economic impact. It is also associated with high levels of patient discomfort and dissatisfaction. To many patients, PONV is a distressing event that reportedly is more feared than post-operative pain. The cause of PONV is complex and can be due to multiple factors. These factors may include certain characteristics of the patient (such as female gender, non-smoking status, and having experienced PONV in the past), the surgical procedure (intra-abdominal laparoscopic procedures, gynecologic surgeries, breast surgeries), and the type of anesthetic that is used. Untreated, the incidence of post-operative nausea and vomiting (PONV) in high risk patients can reach 70-80%. In addition, it is important to note that PONV can present during the first 24 hours after surgery or beyond. PONV alone is one of the leading causes for delayed discharge and unplanned hospital admission following outpatient surgery. Furthermore, more than 35% of surgical outpatients experience PONV following discharge, many of whom did not experience nausea or vomiting in the recovery room.
An important factor in the development of Post-operative nausea and vomiting (PONV) appears to be the release of the biogenic amine serotonin (5-HT3) in the brainstem and the peripheral nervous system. Serotonin induces nausea and vomiting via the 5-HT3 receptor.
Currently, medications that block the 5-HT3 receptor are widely accepted as a first-line anti-emetic in both the prevention and treatment of PONV. Ondansetron is the most commonly prescribed. An intra-venous dose of Ondansetron administered intra-operatively is predicted to reduce PONV by 15-20% when compared to patients who receive a placebo. However, Ondansetron has a half-life of approximately six hours and must be re-dosed in patients with prolonged or delayed-onset PONV.
By contrast, Palonosetron is another 5-HT3 receptor antagonist that has a longer half-life than Ondansetron, thus reducing the need for re-dosing; a single dose of Palonosetron was shown to be superior to a single dose of Ondansetron in the treatment of delayed nausea and vomiting associated with chemotherapy.
Furthermore, there is now evidence that a multimodal approach to the prevention of post-operative nausea and vomiting is more effective than any single medication. A recent study determined that a combination regimen of Ondansetron and Dexamethasone (a steroid medication known to prevent nausea and vomiting) provided significantly better prophylaxis against PONV than Ondansetron alone.
Therefore, the rationale for conducting this study is to evaluate whether the administration of a single dose of Palonosetron combined with Dexamethasone is superior to a single dose of Palonosetron alone in the prevention of both immediate and delayed PONV in high risk patients undergoing laparoscopic abdominal or gynecologic surgery.
In order to answer the question of whether Palonosetron plus Dexamethasone is significantly more effective at reducing the incidence of PONV than Palonosetron alone, we will enroll patients that are high risk for PONV who are undergoing laparoscopic abdominal or gynecologic surgery. This subset includes: female patients, non-smokers, and patients with a history of PONV.
Each study patient will receive Palonosetron alone or Palonosetron plus Dexamethasone immediately prior to the start of her/his surgery. We will then use an 11 point nausea scale to determine how many patients had a complete response to the medication (complete response = NO nausea and NO vomiting at any time during the study period of 0-72 hours post surgery). If a patient does experience nausea or vomiting, we will record the time and severity of the PONV as well as whether any medication was given to relieve the nausea and vomiting. If a patient is discharged from the hospital before their 72nd hour post surgery, (s)he will receive a journal in which to record any symptoms or nausea or vomiting and a member of the research team will call to obtain the information.
We predict that the combination of Palonosetron plus Dexamethasone will be superior to Palonosetron alone in the prevention of PONV. We will compare the incidence of patients with a complete response to the study medication (NO nausea and NO vomiting for 72 hours post surgery) to determine if this hypothesis is valid.
- Conditions
- PONV
- Being tested
- Palonosetron only, Palonosetron with Dexamethasone
- Keywords
- PONV, Outpatient surgery, Laparoscopic abdominal surgery, Laparoscopic gynecologic 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.
Palonosetron onlyDrug
Also called Palonosetron, Saline Solution
The placebo arm will be given a dose of IV palonosetron only, and saline solution prior to surgery to see how this compares with the other combination.
Palonosetron with DexamethasoneDrug
Also called Palonosetron, Aloxi, Dexamethasone, Decadron
Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery to see if this reduces PONV.
| Study group | Role | What they receive |
|---|---|---|
| Palonosetron with Dexamethasone | Experimental | Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery. Receives: Drug: Palonosetron with Dexamethasone |
| Palonosetron only | Placebo comparator | Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution Receives: Drug: Palonosetron only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate
A Complete Response (CR): defined as no nausea, no vomiting/retching, no rescue medication and no withdrawal of consent from the time of administration of the study drug(s) until 72 hours post emergence from anesthesia.
Measured: Pre-op through 72 hours post emergence from anesthesia
Secondary outcomes (1)
Number of Participants Who Experienced no or Reduced Post-Operative Nausea Vomiting (PONV) the First 96 Hours After Surgery
Participants with no or reduced post operative nausea over a 96 hour period after surgery. questionnaires answered after surgery at 2 hour, 6 hour, 12 hour 72 hour and 96 hours post surgery.
Measured: Pre-op through 96 hours post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2010
- Study completionApr 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PONVStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Sponsor
- Investigators
- Jeanna Blitz, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952133
- Sponsor's protocol ID
- H08-605
- Acronym
- PONV
- Status last verified
- Mar 2015
- First submitted
- 30 Jul 2009
- Last updated
- 17 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Blitz JD, Haile M, Kline R, Franco L, Didehvar S, Pachter HL, Newman E, Bekker A. A randomized double blind study to evaluate efficacy of palonosetron with dexamethasone versus palonosetron alone for prevention of postoperative and postdischarge nausea and vomiting in subjects undergoing laparoscopic surgeries with high emetogenic risk. Am J Ther. 2012 Sep;19(5):324-9. doi: 10.1097/MJT.0b013e318209dff1.
PubMed 21519222
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Study to Evaluate the Efficacy of IV Palo w/ IV Dexamethasone vs IV Palo for Prevention of Immediate & Delayed Post-Operative Nausea/Vomiting in Subj Undergoing Laparoscopic Surgeries w/a High Emetogenic Risk
- ClinicalTrials.gov ID
- NCT00952133
- Acronym / sponsor ID
- PONV / H08-605
- Conditions
- PONV
- Keywords
- PONV, Outpatient surgery, Laparoscopic abdominal surgery, Laparoscopic gynecologic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 4 Aug 2009 (estimated)
- Results
- Posted 31 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if subjects who receive Palonosetron plus Dexamethasone have less post-operative nausea and vomiting (PONV) than those who receive Palonosetron alone.
Detailed description
Post-operative nausea and vomiting (PONV) is a frequent complication of surgery, with considerable medical and economic impact. It is also associated with high levels of patient discomfort and dissatisfaction. To many patients, PONV is a distressing event that reportedly is more feared than post-operative pain. The cause of PONV is complex and can be due to multiple factors. These factors may include certain characteristics of the patient (such as female gender, non-smoking status, and having experienced PONV in the past), the surgical procedure (intra-abdominal laparoscopic procedures, gynecologic surgeries, breast surgeries), and the type of anesthetic that is used. Untreated, the incidence of post-operative nausea and vomiting (PONV) in high risk patients can reach 70-80%. In addition, it is important to note that PONV can present during the first 24 hours after surgery or beyond. PONV alone is one of the leading causes for delayed discharge and unplanned hospital admission following outpatient surgery. Furthermore, more than 35% of surgical outpatients experience PONV following discharge, many of whom did not experience nausea or vomiting in the recovery room.
An important factor in the development of Post-operative nausea and vomiting (PONV) appears to be the release of the biogenic amine serotonin (5-HT3) in the brainstem and the peripheral nervous system. Serotonin induces nausea and vomiting via the 5-HT3 receptor.
Currently, medications that block the 5-HT3 receptor are widely accepted as a first-line anti-emetic in both the prevention and treatment of PONV. Ondansetron is the most commonly prescribed. An intra-venous dose of Ondansetron administered intra-operatively is predicted to reduce PONV by 15-20% when compared to patients who receive a placebo. However, Ondansetron has a half-life of approximately six hours and must be re-dosed in patients with prolonged or delayed-onset PONV.
By contrast, Palonosetron is another 5-HT3 receptor antagonist that has a longer half-life than Ondansetron, thus reducing the need for re-dosing; a single dose of Palonosetron was shown to be superior to a single dose of Ondansetron in the treatment of delayed nausea and vomiting associated with chemotherapy.
Furthermore, there is now evidence that a multimodal approach to the prevention of post-operative nausea and vomiting is more effective than any single medication. A recent study determined that a combination regimen of Ondansetron and Dexamethasone (a steroid medication known to prevent nausea and vomiting) provided significantly better prophylaxis against PONV than Ondansetron alone.
Therefore, the rationale for conducting this study is to evaluate whether the administration of a single dose of Palonosetron combined with Dexamethasone is superior to a single dose of Palonosetron alone in the prevention of both immediate and delayed PONV in high risk patients undergoing laparoscopic abdominal or gynecologic surgery.
In order to answer the question of whether Palonosetron plus Dexamethasone is significantly more effective at reducing the incidence of PONV than Palonosetron alone, we will enroll patients that are high risk for PONV who are undergoing laparoscopic abdominal or gynecologic surgery. This subset includes: female patients, non-smokers, and patients with a history of PONV.
Each study patient will receive Palonosetron alone or Palonosetron plus Dexamethasone immediately prior to the start of her/his surgery. We will then use an 11 point nausea scale to determine how many patients had a complete response to the medication (complete response = NO nausea and NO vomiting at any time during the study period of 0-72 hours post surgery). If a patient does experience nausea or vomiting, we will record the time and severity of the PONV as well as whether any medication was given to relieve the nausea and vomiting. If a patient is discharged from the hospital before their 72nd hour post surgery, (s)he will receive a journal in which to record any symptoms or nausea or vomiting and a member of the research team will call to obtain the information.
We predict that the combination of Palonosetron plus Dexamethasone will be superior to Palonosetron alone in the prevention of PONV. We will compare the incidence of patients with a complete response to the study medication (NO nausea and NO vomiting for 72 hours post surgery) to determine if this hypothesis is valid.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palonosetron with Dexamethasone | Experimental | Drug: Palonosetron with DexamethasoneWomen/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery. |
| Palonosetron only | Placebo comparator | Drug: Palonosetron onlyWomen/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Has signed an informed consent form
- Have an American Society of Anesthesiologists (ASA) Physical Status Classification of I, II, or III
- Female, 18-55 years old
- Male, 18-55 years old, who has more than 3 risk factors for PONV
- Undergoing outpatient laparoscopic gynecological surgery or laparoscopic abdominal surgery, scheduled for between 1 and 3 hours duration
Key exclusion criteria (17 listed)
- Has an ASA Physical Status Classification of IV or V
- Is pregnant or breastfeeding
- Has been taking more than 10-15mg of oxycodone, or an equivalent opioid dose, on a regular, daily basis, for more than 3 consecutive days before surgery
- Has received an investigational drug in the precious 30 days or who is schedule to receive any investigational drug during the study period
- Has persistent or recurrent nausea and/or vomiting due to other etiologies, including but not limited to, gastric outlet obstruction, hypercalcemia, active peptic ulcer, increased intracranial pressure, or brain metastases
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 |
|---|---|---|
| Palonosetron onlyAlso: Palonosetron, Saline SolutionThe placebo arm will be given a dose of IV palonosetron only, and saline solution prior to surgery to see how this compares with the other combination. | Drug | Palonosetron only |
| Palonosetron with DexamethasoneAlso: Palonosetron, Aloxi, Dexamethasone, DecadronWomen/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery to see if this reduces PONV. | Drug | Palonosetron with Dexamethasone |
Primary outcome
Complete Response Rate
Time frame: Pre-op through 72 hours post emergence from anesthesia
A Complete Response (CR): defined as no nausea, no vomiting/retching, no rescue medication and no withdrawal of consent from the time of administration of the study drug(s) until 72 hours post emergence from anesthesia.
1 secondary outcome
Number of Participants Who Experienced no or Reduced Post-Operative Nausea Vomiting (PONV) the First 96 Hours After Surgery
Time frame: Pre-op through 96 hours post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21519222Blitz JD, Haile M, Kline R, Franco L, Didehvar S, Pachter HL, Newman E, Bekker A. A randomized double blind study to evaluate efficacy of palonosetron with dexamethasone versus palonosetron alone for prevention of postoperative and postdischarge nausea and vomiting in subjects undergoing laparoscopic surgeries with high emetogenic risk. Am J Ther. 2012 Sep;19(5):324-9. doi: 10.1097/MJT.0b013e318209dff1.
- pubmed abstractLink provided by the sponsor.
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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.
Jeanna Blitz, MD principal investigator
NYU 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 only and Palonosetron with Dexamethasone in people with PONV, run by NYU Langone Health 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 11 inclusion and 17 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 17 Apr 2015. 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 31 Mar 2014). 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?
Complete Response Rate (time frame: Pre-op through 72 hours post emergence from anesthesia). 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 NCT00952133, 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 17 Apr 2015.