Therapeutic Efficacy of Ramosetron for Treatment of Established PONV After Laparoscopic Surgery

Study Overview
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Brief Summary
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Patients who had at least two risk factors of PONV (Postoperative nausea and vomiting) and underwent laparoscopic surgeries under general anesthesia were assessed for eligibility. Patients who developed PONV within the first 2 hours after anesthesia received intravenously, in a randomized double-blind manner, ondansetron 4 mg or ramosetron 0.3 mg. Patients were then observed for 24 hours after drug administration. The incidence of nausea and vomiting, severity of nausea, requirements for rescue antiemetic and adverse effects at 0-2 and 2-24 hours after drug administration were evaluated. The primary endpoint was the rate of patients exhibiting complete response, defined as no emesis and no further rescue antiemetic medication for 24 hours after drug administration.

Conditions
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Abdominal Mass

Intervention / Treatment
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* Drug: Ondansetron
* Drug: Ramosetron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 19-65 years patients undergoing elective laparoscopic surgery under inhalational anesthesia duration of surgery between 30 min to 4 h ASA (American Society of Anesthesiologists) physical status I or II, and patients who had at least two of these risk factors female gender, history of motion sickness (MS) or PONV, nonsmoking, and the use of postoperative opioids. Exclusion Criteria: patients with history of being allergic to 5-HT3 receptor antagonist patients with history of anticancer chemotherapy chronic opioids use, alcohol abuse, or drug abuse patients who took antiemetic medication within 24 h before surgery, steroids within 24 h before surgery or 24 h after surgery presence of renal (serum Cr > 1.6 mg/dl) hepatic(liver enzymes more than 2 times normal value) insufficiency patients converted to open laparotomy patient who are pregnant or breast-feeding patient with borderline QTc(corrected QT interval) prolongation (> 430 ms for male, >450 ms for female) patient not able to understand the scoring of pain or express the degree of PONV.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ondansetron group<br> | Drug: Ondansetron<br>* Ondansetron also has been reported as effective prophylactic and therapeutic 5-HT3 receptor antagonist for the treatment of PONV. Ramosetron has been shown to have a very strong effect for preventing PONV in previous meta-analyses, but in recent report, its clinical significance may be questioned to request for additional study.<br>|
| Experimental: Ramosetron group<br> | Drug: Ramosetron<br>* Ramosetron is a newly developed selective 5-HT3 (5 hydroxytryptamine 3) receptor antagonist with longer duration of action up to 48hours and higher receptor affinity, than its previously developed congeners, including ondansetron.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ratio of complete response | complete response is defined as no retching or vomiting and no secondary rescue antiemetic administration | 24 hours after administration of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of nausea and vomiting |  | 24 hours after administration of study drug |