Postoperative Nausea and VomitingNCT01825733
Comparison of Palonosetron and Ramosetron for Preventing Patient-controlled Analgesia Related Nausea and Vomiting Following Spine Surgery
A study testing ramosetron and palonosetron in people with Postoperative Nausea and Vomiting, run by Yonsei University.
Trial summary
Postoperative pain, the great concern for the patients undergoing spine surgery, has led to common use of opioid-based intravenous patient-controlled analgesia (IV-PCA) postoperatively. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- ramosetron and palonosetron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Jul 2012
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients (20-65 years) scheduled for lumbar spinal surgery in prone position between August 2011 and July 2012.
- All patients were using opioid-based IV-PCA postoperatively for pain control
Who cannot join
- gastrointestinal disease
- renal dysfunction
- hepatic dysfunction
- diabetes mellitus on insulin
- pregnancy
- use of steroid, opioid, antiemetics within 1 day before surgery
- inability to understand verbal rating scale (VRS)
- inability to use PCA device
About this study
Postoperative pain, the great concern for the patients undergoing spine surgery, has led to common use of opioid-based intravenous patient-controlled analgesia (IV-PCA) postoperatively. Opioid-based IV-PCA offers better pain control, which could facilitate early recovery, rehabilitation and increase patient satisfaction. However, its use inevitably increases the incidence of postoperative nausea and vomiting (PONV), another great discomfort, as high as 80% in patients with multiple risk factors.Therefore, there have been consistent efforts to prevent PONV with multimodal therapies such as risk stratification, modification and preventive use of antiemetics.
Of all antiemetics, 5-hydroxytryptamine (5-HT3) antagonist, especially ondansetron, is most commonly used and extensively studied to reduce PONV because of its efficacy and fewer side effects.[8] However, its efficacy is not quite satisfactory when it comes to PONV associated with opioid-based IV-PCA. Recently, there are many reports comparing the antiemetic efficacy between ondansetron and the 2 newly developed 5-HT3 antagonists, ramosetron and palonosetron. Ramosetron is known to have a higher affinity and longer duration of binding to 5-HT3 receptor, therefore exhibits potent and sustained anti-emetic effect than previously developed 5-HT3 antagonists.Palonosetron has a unique allosteric binding to the 5-HT3 receptor, which brings a higher affinity, longer duration of action and longer elimination half-time.According to the previous studies, both ramosetron and palonosetron showed superior antiemetic efficacy for PONV associated with opioid-based IV-PCA to ondansetron as expected by their theoretical advantages. However, it has never been evaluated which one has superior antiemetic efficacy for opioid-based IV-PCA associated PONV. Therefore, in this study, we tried to evaluate the relative antiemetic efficacy of ramosetron and palonosetron in controlling opioid-based IV-PCA related PONV.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- ramosetron, palonosetron
- Keywords
- palonosetron, ramosetron, PONV, opioid
- 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.
ramosetronDrug
Ramosetron 0.3 mg was mixed to the PCA. Same dose of drug was administered 10 minutes before the end of surgery according to the allocated group.
palonosetronDrug
palonosetrno 0.075 mg was mixed to the PCA. Same dose of drug was administered 10 minutes before the end of surgery according to the allocated group.
| Study group | Role | What they receive |
|---|---|---|
| ramosetron | Experimental | Not described Receives: Drug: ramosetron |
| palonosetron | Active comparator | Not described Receives: Drug: palonosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
verbal numeric scale
At each time point, frequency and intensity (verbal numeric scale, 0-10, 0: no nausea, 10: maximum) of nausea, frequency of vomiting, rescue antiemetic use were recorded and compared between groups.
Measured: change of antiemetic efficacy for 5 time points ( postanesthesia care unit, 0-6 h, 6-24 h, 24-48 h, 48-72 h after operation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startAug 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Yonsei 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825733
- Sponsor's protocol ID
- 4-2011-0122
- Status last verified
- Feb 2014
- First submitted
- 26 Mar 2013
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Palonosetron and Ramosetron for Preventing Patient-controlled Analgesia Related Nausea and Vomiting Following Spine Surgery
- ClinicalTrials.gov ID
- NCT01825733
- Acronym / sponsor ID
- 4-2011-0122
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- palonosetron, ramosetron, PONV, opioid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 8 Apr 2013 (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.
Postoperative pain, the great concern for the patients undergoing spine surgery, has led to common use of opioid-based intravenous patient-controlled analgesia (IV-PCA) postoperatively. Opioid-based IV-PCA offers better pain control, which could facilitate early recovery, rehabilitation and increase patient satisfaction. However, its use inevitably increases the incidence of postoperative nausea and vomiting (PONV), another great discomfort, as high as 80% in patients with multiple risk factors.Therefore, there have been consistent efforts to prevent PONV with multimodal therapies such as risk stratification, modification and preventive use of antiemetics.
Of all antiemetics, 5-hydroxytryptamine (5-HT3) antagonist, especially ondansetron, is most commonly used and extensively studied to reduce PONV because of its efficacy and fewer side effects.[8] However, its efficacy is not quite satisfactory when it comes to PONV associated with opioid-based IV-PCA. Recently, there are many reports comparing the antiemetic efficacy between ondansetron and the 2 newly developed 5-HT3 antagonists, ramosetron and palonosetron. Ramosetron is known to have a higher affinity and longer duration of binding to 5-HT3 receptor, therefore exhibits potent and sustained anti-emetic effect than previously developed 5-HT3 antagonists.Palonosetron has a unique allosteric binding to the 5-HT3 receptor, which brings a higher affinity, longer duration of action and longer elimination half-time.According to the previous studies, both ramosetron and palonosetron showed superior antiemetic efficacy for PONV associated with opioid-based IV-PCA to ondansetron as expected by their theoretical advantages. However, it has never been evaluated which one has superior antiemetic efficacy for opioid-based IV-PCA associated PONV. Therefore, in this study, we tried to evaluate the relative antiemetic efficacy of ramosetron and palonosetron in controlling opioid-based IV-PCA related PONV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ramosetron | Experimental | Drug: ramosetron |
| palonosetron | Active comparator | Drug: palonosetron |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients (20-65 years) scheduled for lumbar spinal surgery in prone position between August 2011 and July 2012.
- All patients were using opioid-based IV-PCA postoperatively for pain control
Key exclusion criteria (8 listed)
- gastrointestinal disease
- renal dysfunction
- hepatic dysfunction
- diabetes mellitus on insulin
- pregnancy
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 |
|---|---|---|
| ramosetronRamosetron 0.3 mg was mixed to the PCA. Same dose of drug was administered 10 minutes before the end of surgery according to the allocated group. | Drug | ramosetron |
| palonosetronpalonosetrno 0.075 mg was mixed to the PCA. Same dose of drug was administered 10 minutes before the end of surgery according to the allocated group. | Drug | palonosetron |
Primary outcome
verbal numeric scale
Time frame: change of antiemetic efficacy for 5 time points ( postanesthesia care unit, 0-6 h, 6-24 h, 24-48 h, 48-72 h after operation)
At each time point, frequency and intensity (verbal numeric scale, 0-10, 0: no nausea, 10: maximum) of nausea, frequency of vomiting, rescue antiemetic use were recorded and compared between groups.
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 19 Feb 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ramosetron and palonosetron in people with Postoperative Nausea and Vomiting, run by Yonsei 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 2 inclusion and 8 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 19 Feb 2014. 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.
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?
verbal numeric scale (time frame: change of antiemetic efficacy for 5 time points ( postanesthesia care unit, 0-6 h, 6-24 h, 24-48 h, 48-72 h after operation)). 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 19 Feb 2014.