Abdominal MassNCT03017222
Therapeutic Efficacy of Ramosetron for Treatment of Established PONV After Laparoscopic Surgery
A study testing Ondansetron and Ramosetron in people with Abdominal Mass, run by Yonsei University.
Trial summary
Patients who had at least two risk factors of PONV (Postoperative nausea and vomiting) and underwent laparoscopic surgeries under general anesthesia were assessed for eligibility. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Abdominal Mass
- What is being tested?
- Ondansetron and Ramosetron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 7 Sep 2015to 2 Apr 2016
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 19-65 years
- patients undergoing elective laparoscopic surgery under inhalational anesthesia
- duration of surgery between 30 min to 4 h
- ASA (American Society of Anesthesiologists) physical status I or II, and patients who had at least two of these risk factors
- female gender, history of motion sickness (MS) or PONV, nonsmoking, and the use of postoperative opioids.
Who cannot join
- patients with history of being allergic to 5-HT3 receptor antagonist
- patients with history of anticancer chemotherapy
- chronic opioids use, alcohol abuse, or drug abuse
- patients who took antiemetic medication within 24 h before surgery, steroids within 24 h before surgery or 24 h after surgery
- presence of renal (serum Cr > 1.6 mg/dl)
- hepatic(liver enzymes more than 2 times normal value) insufficiency
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- patients converted to open laparotomy
- patient who are pregnant or breast-feeding
- patient with borderline QTc(corrected QT interval) prolongation (> 430 ms for male, >450 ms for female)
- patient not able to understand the scoring of pain or express the degree of PONV.
About this study
Patients who had at least two risk factors of PONV (Postoperative nausea and vomiting) and underwent laparoscopic surgeries under general anesthesia were assessed for eligibility. Patients who developed PONV within the first 2 hours after anesthesia received intravenously, in a randomized double-blind manner, ondansetron 4 mg or ramosetron 0.3 mg. Patients were then observed for 24 hours after drug administration. The incidence of nausea and vomiting, severity of nausea, requirements for rescue antiemetic and adverse effects at 0-2 and 2-24 hours after drug administration were evaluated. The primary endpoint was the rate of patients exhibiting complete response, defined as no emesis and no further rescue antiemetic medication for 24 hours after drug administration.
- Conditions
- Abdominal Mass
- Being tested
- Ondansetron, Ramosetron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Ondansetron also has been reported as effective prophylactic and therapeutic 5-HT3 receptor antagonist for the treatment of PONV. Ramosetron has been shown to have a very strong effect for preventing PONV in previous meta-analyses, but in recent report, its clinical significance may be questioned to request for additional study.
RamosetronDrug
Ramosetron is a newly developed selective 5-HT3 (5 hydroxytryptamine 3) receptor antagonist with longer duration of action up to 48hours and higher receptor affinity, than its previously developed congeners, including ondansetron.
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron group | Active comparator | Not described Receives: Drug: Ondansetron |
| Ramosetron group | Experimental | Not described Receives: Drug: Ramosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
ratio of complete response
complete response is defined as no retching or vomiting and no secondary rescue antiemetic administration
Measured: 24 hours after administration of study drug
Secondary outcomes (1)
incidence of nausea and vomiting
Measured: 24 hours after administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study start7 Sep 2015
- Primary completion2 Apr 2016
- Study completion2 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal MassStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 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
- NCT03017222
- Sponsor's protocol ID
- 4-2015-0435
- Status last verified
- Jan 2017
- First submitted
- 1 Jan 2017
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Efficacy of Ramosetron for Treatment of Established PONV After Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT03017222
- Acronym / sponsor ID
- 4-2015-0435
- Conditions
- Abdominal Mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 7 Sep 2015
- Primary completion
- 2 Apr 2016 (actual)
- Study completion
- 2 Apr 2016 (actual)
- First posted
- 11 Jan 2017 (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.
Patients who had at least two risk factors of PONV (Postoperative nausea and vomiting) and underwent laparoscopic surgeries under general anesthesia were assessed for eligibility. Patients who developed PONV within the first 2 hours after anesthesia received intravenously, in a randomized double-blind manner, ondansetron 4 mg or ramosetron 0.3 mg. Patients were then observed for 24 hours after drug administration. The incidence of nausea and vomiting, severity of nausea, requirements for rescue antiemetic and adverse effects at 0-2 and 2-24 hours after drug administration were evaluated. The primary endpoint was the rate of patients exhibiting complete response, defined as no emesis and no further rescue antiemetic medication for 24 hours after drug administration.
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 |
|---|---|---|
| Ondansetron group | Active comparator | Drug: Ondansetron |
| Ramosetron group | Experimental | Drug: Ramosetron |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 19-65 years
- patients undergoing elective laparoscopic surgery under inhalational anesthesia
- duration of surgery between 30 min to 4 h
- ASA (American Society of Anesthesiologists) physical status I or II, and patients who had at least two of these risk factors
- female gender, history of motion sickness (MS) or PONV, nonsmoking, and the use of postoperative opioids.
Key exclusion criteria (10 listed)
- patients with history of being allergic to 5-HT3 receptor antagonist
- patients with history of anticancer chemotherapy
- chronic opioids use, alcohol abuse, or drug abuse
- patients who took antiemetic medication within 24 h before surgery, steroids within 24 h before surgery or 24 h after surgery
- presence of renal (serum Cr > 1.6 mg/dl)
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 |
|---|---|---|
| OndansetronOndansetron also has been reported as effective prophylactic and therapeutic 5-HT3 receptor antagonist for the treatment of PONV. Ramosetron has been shown to have a very strong effect for preventing PONV in previous meta-analyses, but in recent report, its clinical significance may be questioned to request for additional study. | Drug | Ondansetron group |
| RamosetronRamosetron is a newly developed selective 5-HT3 (5 hydroxytryptamine 3) receptor antagonist with longer duration of action up to 48hours and higher receptor affinity, than its previously developed congeners, including ondansetron. | Drug | Ramosetron group |
Primary outcome
ratio of complete response
Time frame: 24 hours after administration of study drug
complete response is defined as no retching or vomiting and no secondary rescue antiemetic administration
1 secondary outcome
incidence of nausea and vomiting
Time frame: 24 hours after administration of study drug
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 12 Feb 2019.
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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 Ondansetron and Ramosetron in people with Abdominal Mass, 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 5 inclusion and 10 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 12 Feb 2019. 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?
ratio of complete response (time frame: 24 hours after administration of study drug). 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 12 Feb 2019.