Postoperative Nausea and VomitingNCT02550795
Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer
A study testing Dexmedetomidine and Dexmedetomidine and dexamethasone in people with Postoperative Nausea and Vomiting, run by Gachon University Gil Medical Center.
Trial summary
Previous reports demonstrated that dexmedetomidine could reduce the incidence of postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for ajuvant drugs for preventing and reducing PONV. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Dexmedetomidine and Dexmedetomidine and dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA Physical status I or II female scheduled for breast conserving surgery of modified radical mastectomy.
Who cannot join
- uncontrolled cardiovascular disease
- history of chronic pain
- smoker
- previous history of steroid administraion
- neoajuvant chemotherapy
About this study
Official title: Effects of Single Dose Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer
Previous reports demonstrated that dexmedetomidine could reduce the incidence of postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for ajuvant drugs for preventing and reducing PONV. So investigator want to study about the effect of dexmedetomidine only or combined with dexamethasone for preventing PONV.
Read the detailed description
Previous reports demonstrated that dexmedetomidine, a alpha 2 selective agonist could reduce the incidence of postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for ajuvant drugs for preventing and reducing PONV. So investigator want to study about the effect of dexmedetomidine only or combined with dexamethasone for preventing PONV.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Dexmedetomidine, Dexmedetomidine and dexamethasone, Control
- 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.
DexmedetomidineDrug
Also called DO
administration of dexmedetomidine only
Dexmedetomidine and dexamethasoneDrug
Also called DD
administration of dexmedetomidine and dexamethasone
ControlDrug
Also called OO
administration of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | administration of 0.9% normal saline 10ml Receives: Drug: Control |
| Dexmedetomidine | Active comparator | administration of 0.5ug/kg of dexmedetomidine (5ml) Receives: Drug: Dexmedetomidine |
| Dexmedetomidine and dexamethasone | Active comparator | administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml) Receives: Drug: Dexmedetomidine and dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Nausea (Numeric Rating Scale for Nausea)
Numeric rating scale for postoperative nausea (scores on a scale) (0-no symptoms; 10-worst symptoms imaginable). Ramosetron 0.3 mg was administered to patients with nausea >5 points on the numeric rating scale
Measured: Changes from baseline in postoperative nausea at 30 min
Secondary outcomes (2)
Postoperative Vomiting (Number of Participants With Vomiting)
frequencies of vomiting (number of participants with vomiting) 24 hour post-operatively
Measured: Changes from baseline in postoperative nausea at 30 min
Rhodes Index Score
Rhodes Index of nausea, vomiting, and retching at 6 to 24 hours after surgery (ask 8 question about discomfort due to PONV and each questions are consist of 0~4 score) (minimal PONV 0 to maximal PONV 32) lower values represent a bettwer outcome
Measured: assessed at 6 and 24 hour after operative end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youn Yi Jo, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550795
- Sponsor's protocol ID
- Breast PONV
- Other IDs
- GCIRB2014
- Status last verified
- Aug 2020
- First submitted
- 30 Aug 2015
- Last updated
- 24 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Single Dose Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer
- ClinicalTrials.gov ID
- NCT02550795
- Acronym / sponsor ID
- Breast PONV
- Conditions
- Postoperative Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Posted 24 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous reports demonstrated that dexmedetomidine could reduce the incidence of postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for ajuvant drugs for preventing and reducing PONV. So investigator want to study about the effect of dexmedetomidine only or combined with dexamethasone for preventing PONV.
Detailed description
Previous reports demonstrated that dexmedetomidine, a alpha 2 selective agonist could reduce the incidence of postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for ajuvant drugs for preventing and reducing PONV. So investigator want to study about the effect of dexmedetomidine only or combined with dexamethasone for preventing PONV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Controladministration of 0.9% normal saline 10ml |
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidineadministration of 0.5ug/kg of dexmedetomidine (5ml) |
| Dexmedetomidine and dexamethasone | Active comparator | Drug: Dexmedetomidine and dexamethasoneadministration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA Physical status I or II female scheduled for breast conserving surgery of modified radical mastectomy.
Key exclusion criteria (5 listed)
- uncontrolled cardiovascular disease
- history of chronic pain
- smoker
- previous history of steroid administraion
- neoajuvant chemotherapy
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 |
|---|---|---|
| DexmedetomidineAlso: DOadministration of dexmedetomidine only | Drug | Dexmedetomidine |
| Dexmedetomidine and dexamethasoneAlso: DDadministration of dexmedetomidine and dexamethasone | Drug | Dexmedetomidine and dexamethasone |
| ControlAlso: OOadministration of normal saline | Drug | Control |
Primary outcome
Postoperative Nausea (Numeric Rating Scale for Nausea)
Time frame: Changes from baseline in postoperative nausea at 30 min
Numeric rating scale for postoperative nausea (scores on a scale) (0-no symptoms; 10-worst symptoms imaginable). Ramosetron 0.3 mg was administered to patients with nausea >5 points on the numeric rating scale
2 secondary outcomes
Postoperative Vomiting (Number of Participants With Vomiting)
Time frame: Changes from baseline in postoperative nausea at 30 min
Rhodes Index Score
Time frame: assessed at 6 and 24 hour after operative end
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Dexmedetomidine and Dexmedetomidine and dexamethasone in people with Postoperative Nausea and Vomiting, run by Gachon University Gil Medical Center.
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 5 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 24 Aug 2020. 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. 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?
Yes. Results are posted in the registry (first posted 24 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Postoperative Nausea (Numeric Rating Scale for Nausea) (time frame: Changes from baseline in postoperative nausea at 30 min). 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 24 Aug 2020.