Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Single Dose Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Dexmedetomidine and dexamethasone
* Drug: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA Physical status I or II female scheduled for breast conserving surgery of modified radical mastectomy. Exclusion Criteria: uncontrolled cardiovascular disease history of chronic pain smoker previous history of steroid administraion neoajuvant chemotherapy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>administration of 0.9% normal saline 10ml | Drug: Control<br>* administration of normal saline<br>* Other names: OO;|
| Active Comparator: Dexmedetomidine<br>administration of 0.5ug/kg of dexmedetomidine (5ml) | Drug: Dexmedetomidine<br>* administration of dexmedetomidine only<br>* Other names: DO;|
| Active Comparator: Dexmedetomidine and dexamethasone<br>administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml) | Drug: Dexmedetomidine and dexamethasone<br>* administration of dexmedetomidine and dexamethasone<br>* Other names: DD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |