Postoperative Nausea and VomitingPhase 4NCT01427127
Effect of Ramosetron on Bowel Motility After Colorectal Resection
A Phase 4 study testing Ramosetron in people with Postoperative Nausea and Vomiting, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial summary
Ramosetron is effective in preventing postoperative nausea and vomiting. Several studies reported that ramosetron is also effective treatment diarrhea-predominant irritable bowel syndrome. The investigators examine the effect of ramosetron used for preventing postoperative nausea and vomiting on bowel motility. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Ramosetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2010to Dec 2011
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20-70 yr of age,
- ASA I or II,
- scheduled for laparoscopic colorectal surgery
Who cannot join
- antiemetic use within 24hr prior to surgery
- steroid use within 24hr prior to surgery or 48hr after surgery
- insulin dependent DM
- cardiovascular or pulmonary disease
- renal or hepatic insufficiency
- BMI >=35kg/m2
- pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
School of Medicine, Kyung Hee University
Seoul, 130-702
About this study
Official title: Effect of Ramosetron on Bowel Motility and PONV After Laparoscopic Stomach and Colorectal Resection
Ramosetron is effective in preventing postoperative nausea and vomiting. Several studies reported that ramosetron is also effective treatment diarrhea-predominant irritable bowel syndrome. The investigators examine the effect of ramosetron used for preventing postoperative nausea and vomiting on bowel motility.
Read the detailed description
Ramosetron, a new potent and long-acting selective 5-HT3 receptor antagonist, is effective for preventing postoperative nausea and vomiting. Also several studies reported that ramosetron is effective treatment of irritable bowel syndrome because it inhibits the accelerated colonic transit, abnormal colonic water transport, defecation abnormality, and the lowered colonic perceptual threshold by corticotrophin-releasing hormone. There is no study about the effect of ramosetron used for preventing postoperative nausea and vomiting on postoperative bowel motility. In this study, the investigators examine the effect of ramosetron on postoperative bowel motility.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Ramosetron
- 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 nasea (Astellas Pharma Korea, Inc.)
Patients received intravenous ramosetron 0.3 mg at end of surgery and 24hr after surgery.
| Study group | Role | What they receive |
|---|---|---|
| ramosetron | Experimental | Patients received intravenous ramosetron 0.3 mg at the end of surgery and 24hr after surgery. Receives: Drug: Ramosetron |
| Normal saline | Placebo comparator | Patients received intravenous normal saline at end of surgery and 24hr after surgery. Receives: Drug: Ramosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
time from surgery to passage of gas
Measured: within 10days after surgery
time from surgery to defecation
Measured: within 10 days after surgery
Secondary outcomes (1)
incidence and severity of postoperative nausea and vomiting
incidence: number of patients who experienced postoperative nausea and vomiting severity: verbal rating scale (VRS, 11 point scale) 0= no nausea to 10 = worst possible nausea
Measured: 0 - 6 hours, 6-24 hours, and 24-48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mi Kyeong Kim, Kyunghee University Medical Center
- Investigators
- Mi Kyeong Kim, Principal investigator, School of Medicine, Kyung Hee University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427127
- Sponsor's protocol ID
- RAMS
- Status last verified
- Aug 2011
- First submitted
- 25 Aug 2011
- Last updated
- 1 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ramosetron on Bowel Motility and PONV After Laparoscopic Stomach and Colorectal Resection
- ClinicalTrials.gov ID
- NCT01427127
- Acronym / sponsor ID
- RAMS
- Conditions
- Postoperative Nausea and Vomiting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 1 Sep 2011 (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.
Ramosetron is effective in preventing postoperative nausea and vomiting. Several studies reported that ramosetron is also effective treatment diarrhea-predominant irritable bowel syndrome. The investigators examine the effect of ramosetron used for preventing postoperative nausea and vomiting on bowel motility.
Detailed description
Ramosetron, a new potent and long-acting selective 5-HT3 receptor antagonist, is effective for preventing postoperative nausea and vomiting. Also several studies reported that ramosetron is effective treatment of irritable bowel syndrome because it inhibits the accelerated colonic transit, abnormal colonic water transport, defecation abnormality, and the lowered colonic perceptual threshold by corticotrophin-releasing hormone. There is no study about the effect of ramosetron used for preventing postoperative nausea and vomiting on postoperative bowel motility. In this study, the investigators examine the effect of ramosetron on postoperative bowel motility.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ramosetron | Experimental | Drug: RamosetronPatients received intravenous ramosetron 0.3 mg at the end of surgery and 24hr after surgery. |
| Normal saline | Placebo comparator | Drug: RamosetronPatients received intravenous normal saline at end of surgery and 24hr after surgery. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20-70 yr of age,
- ASA I or II,
- scheduled for laparoscopic colorectal surgery
Key exclusion criteria (7 listed)
- antiemetic use within 24hr prior to surgery
- steroid use within 24hr prior to surgery or 48hr after surgery
- insulin dependent DM
- cardiovascular or pulmonary disease
- renal or hepatic insufficiency
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: nasea (Astellas Pharma Korea, Inc.)Patients received intravenous ramosetron 0.3 mg at end of surgery and 24hr after surgery. | Drug | Normal saline, ramosetron |
Primary outcome
time from surgery to passage of gas
Time frame: within 10days after surgery
time from surgery to defecation
Time frame: within 10 days after surgery
1 secondary outcome
incidence and severity of postoperative nausea and vomiting
Time frame: 0 - 6 hours, 6-24 hours, and 24-48 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2011.
Related trials for Postoperative Nausea and Vomiting
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
Not yet recruiting
Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
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.
Mi Kyeong Kim principal investigator
School of Medicine, Kyung Hee University
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 Ramosetron in people with Postoperative Nausea and Vomiting, run by Kyunghee University Medical Center at 1 site in South Korea.
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 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: status not confirmed, as of the sponsor's last update on 1 Sep 2011. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mi Kyeong Kim, Professor (82-2-958-8604 ext. 92-2-958-8114, mkanes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time from surgery to passage of gas (time frame: within 10days after surgery). The study lists 2 primary outcomes in all. 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 1 Sep 2011.