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| ID | Type | Description | Link |
|---|---|---|---|
| GCIRB2014 | Registry Identifier | GCIRB2014-154 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | administration of 0.9% normal saline 10ml |
|
| Dexmedetomidine | Active Comparator | administration of 0.5ug/kg of dexmedetomidine (5ml) |
|
| Dexmedetomidine and dexamethasone | Active Comparator | administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | administration of dexmedetomidine only |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Changes from baseline in postoperative nausea at 30 min |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Vomiting (Number of Participants With Vomiting) | frequencies of vomiting (number of participants with vomiting) 24 hour post-operatively | Changes from baseline in postoperative nausea at 30 min |
| Rhodes Index Score |
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Inclusion Criteria:
Exclusion Criteria:
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There was no one who excluded before assignment to groups
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | administration of 0.9% normal saline 10ml Control: administration of normal saline |
| FG001 | Dexmedetomidine | administration of 0.5ug/kg of dexmedetomidine (5ml) Dexmedetomidine: administration of dexmedetomidine only |
| FG002 | Dexmedetomidine and Dexamethasone | administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml) Dexmedetomidine and dexamethasone: administration of dexmedetomidine and dexamethasone |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | administration of 0.9% normal saline 10ml Control: administration of normal saline |
| BG001 | Dexmedetomidine | administration of 0.5ug/kg of dexmedetomidine (5ml) Dexmedetomidine: administration of dexmedetomidine only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | one patient excluded from the analysis according to changes of surgery method |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Patients who underwent breast cancer surgery | Posted | Median | Inter-Quartile Range | scores on a scale | Changes from baseline in postoperative nausea at 30 min |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | administration of 0.9% normal saline 10ml Control: administration of normal saline |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Youn Yi Jo | Gil hospital | 82324603636 | endless37@gilhospital.com |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Dexmedetomidine and dexamethasone | Drug | administration of dexmedetomidine and dexamethasone |
|
|
| Control | Drug | administration of normal saline |
|
|
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
| assessed at 6 and 24 hour after operative end |
| BG002 | Dexmedetomidine and Dexamethasone | administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml) Dexmedetomidine and dexamethasone: administration of dexmedetomidine and dexamethasone |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Dexmedetomidine and Dexamethasone | administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml) Dexmedetomidine and dexamethasone: administration of dexmedetomidine and dexamethasone |
|
|
| Secondary | Postoperative Vomiting (Number of Participants With Vomiting) | frequencies of vomiting (number of participants with vomiting) 24 hour post-operatively | Patients who underwent breast cancer surgery | Posted | Number | participants | Changes from baseline in postoperative nausea at 30 min |
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | score on a scale | assessed at 6 and 24 hour after operative end |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Dexmedetomidine | administration of 0.5ug/kg of dexmedetomidine (5ml) Dexmedetomidine: administration of dexmedetomidine only | 0 | 50 | 0 | 50 | 0 | 50 |
| EG002 | Dexmedetomidine and Dexamethasone | administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml) Dexmedetomidine and dexamethasone: administration of dexmedetomidine and dexamethasone | 0 | 50 | 0 | 50 | 0 | 50 |
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| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D011246 |
| Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| Male |
|
| Title | Measurements |
|---|---|
|
| 6-24hour |
|
|