Postoperative Nausea and VomitingPhase 4NCT02635828
Effectiveness of Triple Therapy With Palonosetron for PON Prophylaxis
A Phase 4 study testing Palonosetron 0.075 mg IV, Dexamethasone 10 mg IV and Promethazine 25 mg IV in people with Postoperative Nausea and Vomiting, run by Ohio State University.
Trial summary
Postoperative nausea and vomiting (PONV) is a displeasing experience that distresses surgical patients during the first 24 hours after a surgical procedure. The incidence of postoperative nausea occurs in about 50%, the incidence of postoperative vomiting is about 30%, and in high-risk patients, the PONV rate could be… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Palonosetron 0.075 mg IV, Dexamethasone 10 mg IV and Promethazine 25 mg IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Oct 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, 18 to 85 years of age, of any race or gender. With an American Society of Anesthesiologist (ASA) physical status of I to III who are scheduled to undergo neurological surgery requiring opening of the cranium and Dura matter under general anesthesia, at Ohio State University Medical Center and who consent in writing to participating in this study.
- Post operative hospitalization expected to last at least 72 hours.
- Subjects whose surgery is expected to require at least 1 hours of general anesthesia
- Subjects who have a negative serum or urine pregnancy test within 1 day of surgery or who have been surgically sterilized or are postmenopausal.
Who cannot join
- Subjects who are prisoners, pregnant, mentally ill, under the age of 18 or over the age of 85, ASA classification of V, alcohol or drug abusers.
- Subjects with known hypersensitivity to any 5-HT3 antagonist, to any agent that is part of the anesthesia regimen, or to other medications to be administered under this protocol.
- Subjects who are breastfeeding.
- Subjects who have had retching/vomiting or moderate to severe nausea in the 24 hours prior to anesthesia or suffer chronic nausea and/or vomiting
- Subjects who have been treated with any drug or other treatment with anti-emetic efficacy within the last 24 hours prior to the start of treatment.
- Subjects who have participated in a clinical trial of an investigational drug within 30 days prior to surgery.
- Subjects who are participating in any other clinical study
About this study
Official title: Studying the Effectiveness of Triple Therapy With Palonosetron, Dexamethasone and Promethazine for Prevention of Post Operative Nausea and Vomiting in High Risk Patients Undergoing Neurological Surgery and General Anesthesia
Postoperative nausea and vomiting (PONV) is a displeasing experience that distresses surgical patients during the first 24 hours after a surgical procedure. The incidence of postoperative nausea occurs in about 50%, the incidence of postoperative vomiting is about 30%, and in high-risk patients, the PONV rate could be as high as 80%. Therefore, the study design of this single arm, non-randomized, pilot study assessed the efficacy and safety profile of a triple therapy combination with palonosetron, dexamethasone and promethazine to prevent PONV in patients undergoing craniotomies under general anesthesia.
Read the detailed description
At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis. After surgery, subjects were transferred to the surgical intensive care unit (SICU) or post anesthesia care unit as clinically indicated. Ondansetron 4 mg IV was administered as primary rescue medication to subjects with PONV symptoms. PONV was assessed and collected every 24 hours for 5 days via direct interview and/or medical charts review.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Palonosetron 0.075 mg IV, Dexamethasone 10 mg IV, Promethazine 25 mg IV
- Keywords
- Palonosetron, Craniotomy, Nausea, Vomiting
- Medical subject headings
- Postoperative Nausea and Vomiting, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palonosetron 0.075 mg IVDrug
Also called Aloxi
At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.
Dexamethasone 10 mg IVDrug
Also called Decadron
At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.
Promethazine 25 mg IVDrug
Also called Phenergan
At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis.
| Study group | Role | What they receive |
|---|---|---|
| Triple therapy PONV prophylaxis | Experimental | At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis. Receives: Drug: Palonosetron 0.075 mg IV; Drug: Dexamethasone 10 mg IV; Drug: Promethazine 25 mg IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
PONV Incidence
The incidence of PONV
Measured: 24 hours after end of surgery
Secondary outcomes (1)
Incidence of Subjects Significant QTc Changes in the EKG
The incidence of significant QTc prolongation was measured by comparing baseline EKG, 24 hours and 120 hours after surgery
Measured: 24 and 120 hours/discharge after end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startOct 2009
- Primary completionMay 2011
- Study completionOct 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 (20)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Principal investigator, Sergio Bergese, Ohio State University
- Investigators
- Alberto A Uribe, M.D., Study chair, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635828
- Sponsor's protocol ID
- 2008H0170
- Status last verified
- Mar 2017
- First submitted
- 8 Dec 2015
- Last updated
- 5 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Publications
Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999 Sep;89(3):652-8. doi: 10.1097/00000539-199909000-00022.
PubMed 10475299Kovac AL. Prevention and treatment of postoperative nausea and vomiting. Drugs. 2000 Feb;59(2):213-43. doi: 10.2165/00003495-200059020-00005.
PubMed 10730546Fabling JM, Gan TJ, El-Moalem HE, Warner DS, Borel CO. A randomized, double-blinded comparison of ondansetron, droperidol, and placebo for prevention of postoperative nausea and vomiting after supratentorial craniotomy. Anesth Analg. 2000 Aug;91(2):358-61. doi: 10.1097/00000539-200008000-00023.
PubMed 10910848Gan TJ, Meyer T, Apfel CC, Chung F, Davis PJ, Eubanks S, Kovac A, Philip BK, Sessler DI, Temo J, Tramer MR, Watcha M; Department of Anesthesiology, Duke University Medical Center. Consensus guidelines for managing postoperative nausea and vomiting. Anesth Analg. 2003 Jul;97(1):62-71, table of contents. doi: 10.1213/01.ane.0000068580.00245.95.
PubMed 12818945Audibert G, Vial V. [Postoperative nausea and vomiting after neurosurgery (infratentorial and supratentorial surgery)]. Ann Fr Anesth Reanim. 2004 Apr;23(4):422-7. doi: 10.1016/j.annfar.2004.01.005. French.
PubMed 15120791Manninen PH, Raman SK, Boyle K, el-Beheiry H. Early postoperative complications following neurosurgical procedures. Can J Anaesth. 1999 Jan;46(1):7-14. doi: 10.1007/BF03012507.
PubMed 10078396Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
PubMed 10485781Sanger GJ, Andrews PL. Treatment of nausea and vomiting: gaps in our knowledge. Auton Neurosci. 2006 Oct 30;129(1-2):3-16. doi: 10.1016/j.autneu.2006.07.009. Epub 2006 Aug 24.
PubMed 16934536Habib AS, Gan TJ. Combination therapy for postoperative nausea and vomiting - a more effective prophylaxis? Ambul Surg. 2001 Jul;9(2):59-71. doi: 10.1016/s0966-6532(01)00103-2.
PubMed 11454483Ku CM, Ong BC. Postoperative nausea and vomiting: a review of current literature. Singapore Med J. 2003 Jul;44(7):366-74.
PubMed 14620731Habib AS, El-Moalem HE, Gan TJ. The efficacy of the 5-HT3 receptor antagonists combined with droperidol for PONV prophylaxis is similar to their combination with dexamethasone. A meta-analysis of randomized controlled trials. Can J Anaesth. 2004 Apr;51(4):311-9. doi: 10.1007/BF03018234.
PubMed 15064259Khalil S, Philbrook L, Rabb M, Wells L, Aves T, Villanueva G, Amhan M, Chuang AZ, Lemak NA. Ondansetron/promethazine combination or promethazine alone reduces nausea and vomiting after middle ear surgery. J Clin Anesth. 1999 Nov;11(7):596-600. doi: 10.1016/s0952-8180(99)00103-8.
PubMed 10624646Board T, Board R. The role of 5-HT3 receptor antagonists in preventing postoperative nausea and vomiting. AORN J. 2006 Jan;83(1):209-16, 219-20. doi: 10.1016/s0001-2092(06)60241-x.
PubMed 16528908Siddiqui MA, Scott LJ. Palonosetron. Drugs. 2004;64(10):1125-32; discussion 1133-4. doi: 10.2165/00003495-200464100-00006.
PubMed 15139789Rojas C, Stathis M, Thomas AG, Massuda EB, Alt J, Zhang J, Rubenstein E, Sebastiani S, Cantoreggi S, Snyder SH, Slusher B. Palonosetron exhibits unique molecular interactions with the 5-HT3 receptor. Anesth Analg. 2008 Aug;107(2):469-78. doi: 10.1213/ane.0b013e318172fa74.
PubMed 18633025
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying the Effectiveness of Triple Therapy With Palonosetron, Dexamethasone and Promethazine for Prevention of Post Operative Nausea and Vomiting in High Risk Patients Undergoing Neurological Surgery and General Anesthesia
- ClinicalTrials.gov ID
- NCT02635828
- Acronym / sponsor ID
- 2008H0170
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Palonosetron, Craniotomy, Nausea, Vomiting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- Oct 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 21 Dec 2015 (estimated)
- Results
- Posted 5 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative nausea and vomiting (PONV) is a displeasing experience that distresses surgical patients during the first 24 hours after a surgical procedure. The incidence of postoperative nausea occurs in about 50%, the incidence of postoperative vomiting is about 30%, and in high-risk patients, the PONV rate could be as high as 80%. Therefore, the study design of this single arm, non-randomized, pilot study assessed the efficacy and safety profile of a triple therapy combination with palonosetron, dexamethasone and promethazine to prevent PONV in patients undergoing craniotomies under general anesthesia.
Detailed description
At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis. After surgery, subjects were transferred to the surgical intensive care unit (SICU) or post anesthesia care unit as clinically indicated. Ondansetron 4 mg IV was administered as primary rescue medication to subjects with PONV symptoms. PONV was assessed and collected every 24 hours for 5 days via direct interview and/or medical charts review.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triple therapy PONV prophylaxis | Experimental | Drug: Palonosetron 0.075 mg IV, Drug: Dexamethasone 10 mg IV, Drug: Promethazine 25 mg IVAt induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients, 18 to 85 years of age, of any race or gender. With an American Society of Anesthesiologist (ASA) physical status of I to III who are scheduled to undergo neurological surgery requiring opening of the cranium and Dura matter under general anesthesia, at Ohio State University Medical Center and who consent in writing to participating in this study.
- Post operative hospitalization expected to last at least 72 hours.
- Subjects whose surgery is expected to require at least 1 hours of general anesthesia
- Subjects who have a negative serum or urine pregnancy test within 1 day of surgery or who have been surgically sterilized or are postmenopausal.
Key exclusion criteria (7 listed)
- Subjects who are prisoners, pregnant, mentally ill, under the age of 18 or over the age of 85, ASA classification of V, alcohol or drug abusers.
- Subjects with known hypersensitivity to any 5-HT3 antagonist, to any agent that is part of the anesthesia regimen, or to other medications to be administered under this protocol.
- Subjects who are breastfeeding.
- Subjects who have had retching/vomiting or moderate to severe nausea in the 24 hours prior to anesthesia or suffer chronic nausea and/or vomiting
- Subjects who have been treated with any drug or other treatment with anti-emetic efficacy within the last 24 hours prior to the start of treatment.
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 0.075 mg IVAlso: AloxiAt induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis. | Drug | Triple therapy PONV prophylaxis |
| Dexamethasone 10 mg IVAlso: DecadronAt induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis. | Drug | Triple therapy PONV prophylaxis |
| Promethazine 25 mg IVAlso: PhenerganAt induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis. | Drug | Triple therapy PONV prophylaxis |
Primary outcome
PONV Incidence
Time frame: 24 hours after end of surgery
The incidence of PONV
1 secondary outcome
Incidence of Subjects Significant QTc Changes in the EKG
Time frame: 24 and 120 hours/discharge after end of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 10475299Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999 Sep;89(3):652-8. doi: 10.1097/00000539-199909000-00022.
- Results publication: PubMed 10730546Kovac AL. Prevention and treatment of postoperative nausea and vomiting. Drugs. 2000 Feb;59(2):213-43. doi: 10.2165/00003495-200059020-00005.
- Results publication: PubMed 10910848Fabling JM, Gan TJ, El-Moalem HE, Warner DS, Borel CO. A randomized, double-blinded comparison of ondansetron, droperidol, and placebo for prevention of postoperative nausea and vomiting after supratentorial craniotomy. Anesth Analg. 2000 Aug;91(2):358-61. doi: 10.1097/00000539-200008000-00023.
- Results publication: PubMed 12818945Gan TJ, Meyer T, Apfel CC, Chung F, Davis PJ, Eubanks S, Kovac A, Philip BK, Sessler DI, Temo J, Tramer MR, Watcha M; Department of Anesthesiology, Duke University Medical Center. Consensus guidelines for managing postoperative nausea and vomiting. Anesth Analg. 2003 Jul;97(1):62-71, table of contents. doi: 10.1213/01.ane.0000068580.00245.95.
- Results publication: PubMed 15120791Audibert G, Vial V. [Postoperative nausea and vomiting after neurosurgery (infratentorial and supratentorial surgery)]. Ann Fr Anesth Reanim. 2004 Apr;23(4):422-7. doi: 10.1016/j.annfar.2004.01.005. French.
- Results publication: PubMed 10078396Manninen PH, Raman SK, Boyle K, el-Beheiry H. Early postoperative complications following neurosurgical procedures. Can J Anaesth. 1999 Jan;46(1):7-14. doi: 10.1007/BF03012507.
- Results publication: PubMed 10485781Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
- Results publication: PubMed 16934536Sanger GJ, Andrews PL. Treatment of nausea and vomiting: gaps in our knowledge. Auton Neurosci. 2006 Oct 30;129(1-2):3-16. doi: 10.1016/j.autneu.2006.07.009. Epub 2006 Aug 24.
- Results publication: PubMed 11454483Habib AS, Gan TJ. Combination therapy for postoperative nausea and vomiting - a more effective prophylaxis? Ambul Surg. 2001 Jul;9(2):59-71. doi: 10.1016/s0966-6532(01)00103-2.
- Results publication: PubMed 14620731Ku CM, Ong BC. Postoperative nausea and vomiting: a review of current literature. Singapore Med J. 2003 Jul;44(7):366-74.
- Results publication: PubMed 15064259Habib AS, El-Moalem HE, Gan TJ. The efficacy of the 5-HT3 receptor antagonists combined with droperidol for PONV prophylaxis is similar to their combination with dexamethasone. A meta-analysis of randomized controlled trials. Can J Anaesth. 2004 Apr;51(4):311-9. doi: 10.1007/BF03018234.
- Results publication: PubMed 10624646Khalil S, Philbrook L, Rabb M, Wells L, Aves T, Villanueva G, Amhan M, Chuang AZ, Lemak NA. Ondansetron/promethazine combination or promethazine alone reduces nausea and vomiting after middle ear surgery. J Clin Anesth. 1999 Nov;11(7):596-600. doi: 10.1016/s0952-8180(99)00103-8.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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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.
Alberto A Uribe, M.D. study chair
Ohio State University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Palonosetron 0.075 mg IV, Dexamethasone 10 mg IV and Promethazine 25 mg IV in people with Postoperative Nausea and Vomiting, run by Ohio State University.
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 4 inclusion and 7 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 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 5 May 2017). 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?
PONV Incidence (time frame: 24 hours after end of 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 NCT02635828, which also lists 20 linked publications.
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 5 May 2017.