Ramosetron on Late PONV (Postoperative Nausea and Vomiting)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the effectiveness of additional ramosetron injection for controlling late postoperative nausea and vomiting (PONV) after breast surgery in high risk PONV patients. The investigators compared PONV amomng 3 groups- group C: no additional ramosteron, group B: two additional ramosteron doses at 12 hour interval, group M: two additional ramosetron doses mix to the intraveonus patient controlled analgesia.

Detailed Description
-----------------
The investigators included high risk patients of PONV with a score of 3 or more as measured by the Apfel's score and over 18 years old who receive breast surgery and intravenous patient controlled analgesia. All patients was received ramosetron 0.3 mg at the end of surgery. The patients were evaluated for number of PONV (nausea, vomiting, retching) at 1, 6, 24, and 48 hours postoperatively. Nausea was defined as an unpleasant feeling of vomiting. Retching was defined as an excessive contraction or a regular movement. of the respiratory muscles where no gastric contents were excreted, and vomiting was defined as the excretion of gastric contents. PONV were further detailed quantified using the RINVR score (Rhodes Index of Nausea, Vomiting, and Retching) which enabled the patients' objective and subjective symptoms to be evaluated as a simple and reliable methods. Intravenous injection of ondansetron 4 mg was administered as a rescue antiemetic. The patients were evaluated 2 hours after ondansetron administration. If the symptom persisted, use of second rescue antiemetics dexamethasone 5 mg.

Official Title
-----------------
The Effect of Additional Administration of Ramosetron on Late PONV (Postoperative Nausea and Vomiting) in Patients Undergoing Breast Surgery

Conditions
-----------------
Postoperative Nausea and Vomiting, Breast Cancer Female

Intervention / Treatment
-----------------
* Drug: Ramosetron Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 18 years American Society of Anesthesiologists (ASA) physical status I or II requesting IV PCA (patient control of analgesia) for pain control the high-risk group of PONV with a score of 3 or more as measured by the Apfel's score. Exclusion Criteria: emergency operation re-operation drug abuse, allergy major organ disease (gastrointestinal, cardiovascular, respiratory, cerebral, renal or hepatic disease) smoker pregnancy lactation previously use of antiemetics or systemic steroids within 48 before surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: group C<br>receive ramosetron i.v. 0.3mg at the end of surgery without additional ramosetron | |
| Experimental: group B<br>receive ramosetron i.v. 0.3mg at the end of surgery with two additional doses of ramosetron at 12- and 24- hour postoperative time points | Drug: Ramosetron Hydrochloride<br>* we injected two additional remosetron doses in different way in experimental groups. In group B, patients received additional ramosetron at 12 hour interval, in group M, patients received additional ramosetron in mixed with the patient controlled analgesia regimen.<br>|
| Experimental: group M<br>receive ramosetron i.v. 0.3mg at the end of surgery followed ramosetron 0.6 mg mix with the patient-controlled analgesia (PCA) regimen | Drug: Ramosetron Hydrochloride<br>* we injected two additional remosetron doses in different way in experimental groups. In group B, patients received additional ramosetron at 12 hour interval, in group M, patients received additional ramosetron in mixed with the patient controlled analgesia regimen.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of PONV | number of nausea, vomiting, retching | 24hour postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of PONV | number of nausea, vomiting, retching | 1hour, 6hour, 48 hour postoperatively | 
| Rhodes Index of Nausea, Vomiting, and Retching (RINVR) score | further detaied quantified in PONV experience, total score: 32, none:0, mild: 1-8 point, moderate: 9-16 point, great: 17-24 point, severe: 25-32 point | 1hour, 6hour, 24hour, 48 hour postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mastectomy, postoperative nausea and vomiting, ramosetron