Postoperative Nausea and VomitingNCT02416115
Anti Emetic Efficacy of Combination of Ramosetron and Premixture of Naloxone With Patient-controlled Analgesia
A study testing Ramosetron, Naloxone and saline in people with Postoperative Nausea and Vomiting, run by Kyungpook National University Hospital.
Trial summary
Postoperative nausea and vomiting (PONV) is one of the most undesirable complications after general anesthesia, and may lead to increased hospital stay and health care costs. The risk factors for PONV include sex (female population), nonsmoking status, past history of motion sickness and/or previous PONV, duration of… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Ramosetron, Naloxone and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Sep 2014
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Nonsmoking women (ASA physical status of I or II) scheduled for gynecologic surgery under general anesthesia and postoperative analgesia with a PCA device were included
Who cannot join
- known hypersensitivity to study medication; the use of antiemetics within 24 hours before surgery; the presence of gastrointestinal, renal, hepatic, or psychiatric disease.
About this study
Official title: Anti Emetic Efficacy of Combination of Ramosetron and Premixture of Naloxone With Patient-controlled Analgesia After Gynecologic Surgery
Postoperative nausea and vomiting (PONV) is one of the most undesirable complications after general anesthesia, and may lead to increased hospital stay and health care costs. The risk factors for PONV include sex (female population), nonsmoking status, past history of motion sickness and/or previous PONV, duration of anesthesia and surgical type (particular gynecologic surgery) and postoperative use of opioids. The overall incidence of PONV has been reported to be 30% with considerable variability, but can increase up to 69%- 80% in women undergoing gynecologic surgery with general anesthesia and morphine-patient controlled analgesia (PCA). Serotonin receptor antagonists (5-HT3) have been suggested one of the first line therapies for preventing PONV because of their efficacy and few side effects compared with other antiemetics. However, despite the use of this treatment, the incidence of PONV has been reported to be between 48 % and 50%. Naloxone is a drug used to counter the effects of opioid. It was found that administration of low dose naloxone prevents opioid side effects such as nausea and pruritus without affecting analgesia or opioid requirements in patient receiving morphine PCA. It was reported that the use of two antiemetic acting at different mechanisms is better to prevent PONV than monotherapy.
Therefore, this prospective, randomized, controlled study was designed to investigate the antiemetic efficacy of combination of ramosetron and premixture of naloxone with morphine PCA after gynecologic surgery.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Ramosetron, Naloxone, saline, Morphine
- Keywords
- PONV, ramosetron, naloxone
- 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
Ramosetron was given iv.
NaloxoneDrug
Naloxone added to PCA was given iv.
salineDrug
Saline was given iv.
MorphineDrug
Morphine in the PCA was given iv.
| Study group | Role | What they receive |
|---|---|---|
| R group | Active comparator | Thirty minutes before end of surgery, patients in R group (n=30) received 0.3 mg ramosetron. In the post anesthetic care unit, patients in R group received PCA morphine 1 mg/ml Receives: Drug: Ramosetron; Drug: Morphine |
| N group | Active comparator | Thirty minutes before end of surgery, patients in N group (n=30) received normal saline. In the post anesthetic care unit, group N received PCA mixture of naloxone 1μg/ml and morphine 1 mg/ml. Receives: Drug: Naloxone; Drug: saline; Drug: Morphine |
| RN group | Experimental | Thirty minutes before end of surgery, patients in Ramosetron and naloxone (RN) group (n=30) received 0.3 mg ramosetron. In the post anesthetic care unit, group RN received PCA mixture of naloxone 1μg/ml and morphine 1 mg/ml. Receives: Drug: Ramosetron; Drug: Naloxone; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with postoperative nausea and vomiting
The number of participants with postoperative nausea and vomiting
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startJul 2014
- Primary completionSep 2014
- Study completionSep 2014
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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younghoon Jeon, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416115
- Sponsor's protocol ID
- KNUMC-14-1037
- Status last verified
- Apr 2014
- First submitted
- 7 Apr 2015
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti Emetic Efficacy of Combination of Ramosetron and Premixture of Naloxone With Patient-controlled Analgesia After Gynecologic Surgery
- ClinicalTrials.gov ID
- NCT02416115
- Acronym / sponsor ID
- KNUMC-14-1037
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- PONV, ramosetron, naloxone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 Apr 2015 (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.
Postoperative nausea and vomiting (PONV) is one of the most undesirable complications after general anesthesia, and may lead to increased hospital stay and health care costs. The risk factors for PONV include sex (female population), nonsmoking status, past history of motion sickness and/or previous PONV, duration of anesthesia and surgical type (particular gynecologic surgery) and postoperative use of opioids. The overall incidence of PONV has been reported to be 30% with considerable variability, but can increase up to 69%- 80% in women undergoing gynecologic surgery with general anesthesia and morphine-patient controlled analgesia (PCA). Serotonin receptor antagonists (5-HT3) have been suggested one of the first line therapies for preventing PONV because of their efficacy and few side effects compared with other antiemetics. However, despite the use of this treatment, the incidence of PONV has been reported to be between 48 % and 50%. Naloxone is a drug used to counter the effects of opioid. It was found that administration of low dose naloxone prevents opioid side effects such as nausea and pruritus without affecting analgesia or opioid requirements in patient receiving morphine PCA. It was reported that the use of two antiemetic acting at different mechanisms is better to prevent PONV than monotherapy.
Therefore, this prospective, randomized, controlled study was designed to investigate the antiemetic efficacy of combination of ramosetron and premixture of naloxone with morphine PCA after gynecologic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| R group | Active comparator | Drug: Ramosetron, Drug: MorphineThirty minutes before end of surgery, patients in R group (n=30) received 0.3 mg ramosetron. In the post anesthetic care unit, patients in R group received PCA morphine 1 mg/ml |
| N group | Active comparator | Drug: Naloxone, Drug: saline, Drug: MorphineThirty minutes before end of surgery, patients in N group (n=30) received normal saline. In the post anesthetic care unit, group N received PCA mixture of naloxone 1μg/ml and morphine 1 mg/ml. |
| RN group | Experimental | Drug: Ramosetron, Drug: Naloxone, Drug: MorphineThirty minutes before end of surgery, patients in Ramosetron and naloxone (RN) group (n=30) received 0.3 mg ramosetron. In the post anesthetic care unit, group RN received PCA mixture of naloxone 1μg/ml and morphine 1 mg/ml. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Nonsmoking women (ASA physical status of I or II) scheduled for gynecologic surgery under general anesthesia and postoperative analgesia with a PCA device were included
Key exclusion criteria (1 listed)
- known hypersensitivity to study medication; the use of antiemetics within 24 hours before surgery; the presence of gastrointestinal, renal, hepatic, or psychiatric 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 |
|---|---|---|
| RamosetronRamosetron was given iv. | Drug | R group, RN group |
| NaloxoneNaloxone added to PCA was given iv. | Drug | N group, RN group |
| salineSaline was given iv. | Drug | N group |
| MorphineMorphine in the PCA was given iv. | Drug | N group, R group, RN group |
Primary outcome
The number of participants with postoperative nausea and vomiting
Time frame: 24 hours
The number of participants with postoperative nausea and vomiting
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 22 Feb 2016.
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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 Ramosetron, Naloxone and saline in people with Postoperative Nausea and Vomiting, run by Kyungpook National University Hospital.
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: finished, as of the sponsor's last update on 22 Feb 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.
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?
The number of participants with postoperative nausea and vomiting (time frame: 24 hours). 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 22 Feb 2016.