Postoperative Nausea and VomitingNCT01482468
Continuous Infusion of Palonosetron for Preventing of Postoperative Nausea and Vomiting
A study testing continuous infusion of palonosetron added to prophylactic single injection of palonosetron and continuous infusion of normal saline added to prophylactic single injection of palonosetron in people with Postoperative Nausea and Vomiting, run by Incheon St.Mary's Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether continuous infusion of palonosetron after its prophylactic single injection can further reduce the incidence of postoperative nausea and vomiting in patients undergoing gynecological laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- continuous infusion of palonosetron added to prophylactic single injection of palonosetron and continuous infusion of normal saline added to prophylactic single injection of palonosetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA Physical Status 1 or 2
- Elective gynaecological laparoscopic surgery of ≥ 1h duration
Who cannot join
- Anti-emetics, steroids, or psychoactive medications within 24 h of study initiation
- Vomiting or retching in the 24 h preceding surgery
- Cancer chemotherapy within 4 weeks or emetogenic radiotherapy within 8 weeks before study entry
- Ongoing vomiting from gastrointestinal disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Incheon St Mary's hospital
Incheon, 403-720
Soo Kyoung Park, 82-32-280-5410, hardmong@korea.com
About this study
Official title: Effect of Continuous Infusion of Palonosetron Following Single Prophylactic Injection of Palonosetron for Preventing Postoperative Nausea and Vomiting
The purpose of this study is to determine whether continuous infusion of palonosetron after its prophylactic single injection can further reduce the incidence of postoperative nausea and vomiting in patients undergoing gynecological laparoscopic surgery.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- continuous infusion of palonosetron added to prophylactic single injection of palonosetron, continuous infusion of normal saline added to prophylactic single injection of palonosetron
- 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.
continuous infusion of palonosetron added to prophylactic single injection of palonosetronDrug
continuous infusion of palonosetron 0.00075 mg/hour after single injection of palonosetron 0.075mg
continuous infusion of normal saline added to prophylactic single injection of palonosetronDrug
continuous infusion of normal saline after single injection of palonosetron 0.075mg
| Study group | Role | What they receive |
|---|---|---|
| continuous infusion | Active comparator | continuous infusion of palonosetron added to prophylactic single injection of palonosetron Receives: Drug: continuous infusion of palonosetron added to prophylactic single injection of palonosetron |
| singel injection | Placebo comparator | continuous infusion of normal saline added to prophylactic single injection of palonosetron Receives: Drug: continuous infusion of normal saline added to prophylactic single injection of palonosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative nausea and vomiting
Measured: 24 hours after surgery
Secondary outcomes (1)
severity of nausea
Measured: for 24 hours after sugery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startMar 2012
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incheon St.Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo Kyoung Park, Incheon St.Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482468
- Sponsor's protocol ID
- OC11MISI0109
- Status last verified
- Mar 2012
- First submitted
- 28 Nov 2011
- Last updated
- 23 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Infusion of Palonosetron Following Single Prophylactic Injection of Palonosetron for Preventing Postoperative Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT01482468
- Acronym / sponsor ID
- OC11MISI0109
- Conditions
- Postoperative Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Incheon St.Mary's HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 30 Nov 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.
The purpose of this study is to determine whether continuous infusion of palonosetron after its prophylactic single injection can further reduce the incidence of postoperative nausea and vomiting in patients undergoing gynecological laparoscopic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continuous infusion | Active comparator | Drug: continuous infusion of palonosetron added to prophylactic single injection of palonosetroncontinuous infusion of palonosetron added to prophylactic single injection of palonosetron |
| singel injection | Placebo comparator | Drug: continuous infusion of normal saline added to prophylactic single injection of palonosetroncontinuous infusion of normal saline added to prophylactic single injection of palonosetron |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA Physical Status 1 or 2
- Elective gynaecological laparoscopic surgery of ≥ 1h duration
Key exclusion criteria (4 listed)
- Anti-emetics, steroids, or psychoactive medications within 24 h of study initiation
- Vomiting or retching in the 24 h preceding surgery
- Cancer chemotherapy within 4 weeks or emetogenic radiotherapy within 8 weeks before study entry
- Ongoing vomiting from gastrointestinal disease
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 |
|---|---|---|
| continuous infusion of palonosetron added to prophylactic single injection of palonosetroncontinuous infusion of palonosetron 0.00075 mg/hour after single injection of palonosetron 0.075mg | Drug | continuous infusion |
| continuous infusion of normal saline added to prophylactic single injection of palonosetroncontinuous infusion of normal saline after single injection of palonosetron 0.075mg | Drug | singel injection |
Primary outcome
incidence of postoperative nausea and vomiting
Time frame: 24 hours after surgery
1 secondary outcome
severity of nausea
Time frame: for 24 hours after sugery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2012.
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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 continuous infusion of palonosetron added to prophylactic single injection of palonosetron and continuous infusion of normal saline added to prophylactic single injection of palonosetron in people with Postoperative Nausea and Vomiting, run by Incheon St.Mary's 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 2 inclusion and 4 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 23 Mar 2012. 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.
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 Soo Kyoung Park (82-32-280-5410, hardmong@korea.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postoperative nausea and vomiting (time frame: 24 hours after surgery). 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 23 Mar 2012.