Postoperative Nausea and VomitingPhase 3NCT02830906
Effect of Ramosetron in Prevention of Intrathecal Morphine Induced Nausea and Vomiting
A Phase 3 study testing ramosetron and Ondansetron in people with Postoperative Nausea and Vomiting, run by Thammasat University.
Trial summary
We would like to know the prophylactic anti-emetic effect of ramosetron compare to ondansetron in patient undergone total knee arthroplasty with spinal anesthesia and intrathecal morphine . Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- ramosetron and Ondansetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Mar 2015
- Phase
- Phase 3
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 50-80 years with a diagnosis of primary OA undergoing unilateral TKA
- American Society of Anesthesiologist (ASA) physical status I-III
- Giving written informed consent
Who cannot join
- Body mass index (BMI) > 35 kg/m2
- Unable to undergo spinal anesthesia
- History of allergic to study drugs
- Impaired renal and/or hepatic function
- Use of systemic steroids and anti-emetics within 24 hours of operation
About this study
Official title: Comparison of Ramosetron With Ondansetron for Prevention of Intrathecal Morphine Induced Nausea and Vomiting After Primary Total Knee Arthroplasty: A Randomized Control Trial
We would like to know the prophylactic anti-emetic effect of ramosetron compare to ondansetron in patient undergone total knee arthroplasty with spinal anesthesia and intrathecal morphine .
Read the detailed description
The patients were allocated into 2 groups by computerized block randomization according to a computer generated randomization. Treatment allocations were contained in sealed envelopes that were opened after patient enrollment. Patients received either 8 mg of intravenous (IV) ondansetron or 0.3 mg of IV ramosetron 10 minutes before spinal anesthesia and intrathecal morphine. All of the unilateral TKAs were done by one orthopedic surgeon using the same minimally invasive surgical technique and the same prosthesis.
Patients were monitored for incidence of Post Operative Nausea Vomiting(PONV) every 6 hours until 24 hours, and 24-48 hours postoperatively. Common adverse drug reactions associated with serotonin receptor antagonists (pruritus, dizziness, and headache) were also recorded.
The sample size calculation was based on the ability to detect a difference in incidence of postoperative nausea in between the two groups of 40% i.e. 50% in the ondansetron arm, and 30% in the ramosetron arm, consistent with a previous study. Using a power of 80% (β=0.2) and a two sided significance level(alpha) of 0.05, 45 patients in each group were required.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- ramosetron, Ondansetron
- Keywords
- Total Knee Arthroplasty, Intrathecal Morphine, Ramosetron, Ondansetron, postoperative nausea and vomiting
- 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
Also called ramosetorn
intravenous ramosetron 0.3 mg before spinal anesthesia and intrathecal morphine
OndansetronDrug
intravenous ondansetron 8 mg before spinal anesthesia and intrathecal morphine
| Study group | Role | What they receive |
|---|---|---|
| ramosetron group | Experimental | Patients received 0.3 mg of intravenous ramosetron before spinal anesthesia and intrathecal morphine Receives: Drug: ramosetron |
| ondansetron group | Active comparator | Patients received 8 mg of intravenous ondansetron before spinal anesthesia and intrathecal morphine Receives: Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of postoperative nausea and vomiting
Measured: 48 hours after the operation
Secondary outcomes (2)
number of patients require for anti-emetic medicine
Measured: 48 hours after the operation
visual analog scale for pain
Measured: 48 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startApr 2014
- Primary completionFeb 2015
- Study completionMar 2015
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, piya pinsornsak, Thammasat University
- Investigators
- piya pinsornsak, md, Principal investigator, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830906
- Sponsor's protocol ID
- MTC-EC-OT-2-169/56
- Status last verified
- Jul 2016
- First submitted
- 6 Jul 2016
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ramosetron With Ondansetron for Prevention of Intrathecal Morphine Induced Nausea and Vomiting After Primary Total Knee Arthroplasty: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02830906
- Acronym / sponsor ID
- MTC-EC-OT-2-169/56
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Total Knee Arthroplasty, Intrathecal Morphine, Ramosetron, Ondansetron, postoperative nausea and vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 Jul 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.
We would like to know the prophylactic anti-emetic effect of ramosetron compare to ondansetron in patient undergone total knee arthroplasty with spinal anesthesia and intrathecal morphine .
Detailed description
The patients were allocated into 2 groups by computerized block randomization according to a computer generated randomization. Treatment allocations were contained in sealed envelopes that were opened after patient enrollment. Patients received either 8 mg of intravenous (IV) ondansetron or 0.3 mg of IV ramosetron 10 minutes before spinal anesthesia and intrathecal morphine. All of the unilateral TKAs were done by one orthopedic surgeon using the same minimally invasive surgical technique and the same prosthesis.
Patients were monitored for incidence of Post Operative Nausea Vomiting(PONV) every 6 hours until 24 hours, and 24-48 hours postoperatively. Common adverse drug reactions associated with serotonin receptor antagonists (pruritus, dizziness, and headache) were also recorded.
The sample size calculation was based on the ability to detect a difference in incidence of postoperative nausea in between the two groups of 40% i.e. 50% in the ondansetron arm, and 30% in the ramosetron arm, consistent with a previous study. Using a power of 80% (β=0.2) and a two sided significance level(alpha) of 0.05, 45 patients in each group were required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ramosetron group | Experimental | Drug: ramosetronPatients received 0.3 mg of intravenous ramosetron before spinal anesthesia and intrathecal morphine |
| ondansetron group | Active comparator | Drug: OndansetronPatients received 8 mg of intravenous ondansetron before spinal anesthesia and intrathecal morphine |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 50-80 years with a diagnosis of primary OA undergoing unilateral TKA
- American Society of Anesthesiologist (ASA) physical status I-III
- Giving written informed consent
Key exclusion criteria (5 listed)
- Body mass index (BMI) > 35 kg/m2
- Unable to undergo spinal anesthesia
- History of allergic to study drugs
- Impaired renal and/or hepatic function
- Use of systemic steroids and anti-emetics within 24 hours of operation
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 |
|---|---|---|
| ramosetronAlso: ramosetornintravenous ramosetron 0.3 mg before spinal anesthesia and intrathecal morphine | Drug | ramosetron group |
| Ondansetronintravenous ondansetron 8 mg before spinal anesthesia and intrathecal morphine | Drug | ondansetron group |
Primary outcome
Incidence rate of postoperative nausea and vomiting
Time frame: 48 hours after the operation
2 secondary outcomes
number of patients require for anti-emetic medicine
Time frame: 48 hours after the operation
visual analog scale for pain
Time frame: 48 hours after operation
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 13 Jul 2016.
- 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.
piya pinsornsak, md principal investigator
Thammasat University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ramosetron and Ondansetron in people with Postoperative Nausea and Vomiting, run by Thammasat 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 3 inclusion and 5 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 13 Jul 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 rate of postoperative nausea and vomiting (time frame: 48 hours after the 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 13 Jul 2016.