NauseaNCT01041183
The Effect of Oral and Intravenous Ramosetron During Laparoscopic Cholecystectomy
A study testing intravenous ramosetron, oral ramosetron and oral and IV ramosetron in people with Nausea and Vomiting, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Patients undergoing general anesthesia for laparoscopic cholecystectomy have a high risk of postoperative nausea and vomiting (PONV). The investigators investigated the effect of oral and IV ramosetron on PONV prophylaxis after laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Nausea, Vomiting, Laparoscopic Cholecystectomy
- What is being tested?
- intravenous ramosetron, oral ramosetron and oral and IV ramosetron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2009to Dec 2009
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II patients, 25-65 years, electivelaparoscopic cholecystectomy under general anesthesia
Who cannot join
- GI disease, pregnant or menstruating, history of motion sickness and/or postoperative emesis, antiemetics within 24 h before surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Jung-Hee Ryu
Seongnam-si, Gyeonggi-do, 463-707
Jung-Hee Ryu, Ph.D, 82-31-787-7497, jinaryu@lycos.co.kr
About this study
Patients undergoing general anesthesia for laparoscopic cholecystectomy have a high risk of postoperative nausea and vomiting (PONV). The investigators investigated the effect of oral and IV ramosetron on PONV prophylaxis after laparoscopic cholecystectomy.
- Conditions
- Nausea, Vomiting, Laparoscopic Cholecystectomy
- Being tested
- intravenous ramosetron, oral ramosetron, oral and IV ramosetron
- Keywords
- Oral plus IV ramosetron may be more effective than, IV ramosetron and oral ramosetron for the prophylaxis of, PONV after laparoscopic cholecystectomy
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous ramosetronDrug
0.3 mg IV ramosetron (group I)
oral ramosetronDrug
0.1 mg oral ramosetron (group II)
oral and IV ramosetronDrug
0.1 mg oral ramosetron plus 0.3 mg IV ramosetron (group III).
| Study group | Role | What they receive |
|---|---|---|
| group I | Active comparator | 0.3 mg IV ramosetron Receives: Drug: intravenous ramosetron |
| group II | Active comparator | 0.1 mg oral ramosetron Receives: Drug: oral ramosetron |
| group III | Active comparator | 0.1 mg oral ramosetron plus 0.3 mg IV ramosetron Receives: Drug: oral and IV ramosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PONV
Measured: postoperative 0-48 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NauseaStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041183
- Sponsor's protocol ID
- nasea-LC
- Status last verified
- Nov 2009
- First submitted
- 30 Dec 2009
- Last updated
- 31 Dec 2009
- Results posted
- No
Publications
Ryu JH, Jeon YT, Hwang JW, Oh AY, Moon JY, Ro YJ, Kim CS, Chen C, Apfel CC, Do SH. Intravenous, oral, and the combination of intravenous and oral ramosetron for the prevention of nausea and vomiting after laparoscopic cholecystectomy: a randomized, double-blind, controlled trial. Clin Ther. 2011 Sep;33(9):1162-72. doi: 10.1016/j.clinthera.2011.07.018.
PubMed 21856001
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral and Intravenous Ramosetron During Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT01041183
- Acronym / sponsor ID
- nasea-LC
- Conditions
- Nausea, Vomiting, Laparoscopic Cholecystectomy
- Keywords
- Oral plus IV ramosetron may be more effective than, IV ramosetron and oral ramosetron for the prophylaxis of, PONV after laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2009 (actual)
- First posted
- 31 Dec 2009 (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 undergoing general anesthesia for laparoscopic cholecystectomy have a high risk of postoperative nausea and vomiting (PONV). The investigators investigated the effect of oral and IV ramosetron on PONV prophylaxis after laparoscopic cholecystectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group I | Active comparator | Drug: intravenous ramosetron0.3 mg IV ramosetron |
| group II | Active comparator | Drug: oral ramosetron0.1 mg oral ramosetron |
| group III | Active comparator | Drug: oral and IV ramosetron0.1 mg oral ramosetron plus 0.3 mg IV ramosetron |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I-II patients, 25-65 years, electivelaparoscopic cholecystectomy under general anesthesia
Key exclusion criteria (1 listed)
- GI disease, pregnant or menstruating, history of motion sickness and/or postoperative emesis, antiemetics within 24 h before surgery
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 |
|---|---|---|
| intravenous ramosetron0.3 mg IV ramosetron (group I) | Drug | group I |
| oral ramosetron0.1 mg oral ramosetron (group II) | Drug | group II |
| oral and IV ramosetron0.1 mg oral ramosetron plus 0.3 mg IV ramosetron (group III). | Drug | group III |
Primary outcome
Incidence of PONV
Time frame: postoperative 0-48 h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2009.
- Derived from this study: PubMed 21856001Ryu JH, Jeon YT, Hwang JW, Oh AY, Moon JY, Ro YJ, Kim CS, Chen C, Apfel CC, Do SH. Intravenous, oral, and the combination of intravenous and oral ramosetron for the prevention of nausea and vomiting after laparoscopic cholecystectomy: a randomized, double-blind, controlled trial. Clin Ther. 2011 Sep;33(9):1162-72. doi: 10.1016/j.clinthera.2011.07.018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravenous ramosetron, oral ramosetron and oral and IV ramosetron in people with Nausea and Vomiting, run by Seoul National University Bundang Hospital 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 1 inclusion and 1 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 31 Dec 2009. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung-Hee Ryu, Ph.D (82-31-787-7497, jinaryu@lycos.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of PONV (time frame: postoperative 0-48 h). 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 NCT01041183, which also lists 1 linked publication.
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 31 Dec 2009.