Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting

Study Overview
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Brief Summary
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This study was designed to evaluate the treatment efficacy and safety of palonosetron for the patients who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia.

Detailed Description
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Postoperative nausea and vomiting (PONV) is a frequent complication of surgery, which can produce subject discomfort with medical and economic consequences. This study was designed to evaluate the treatment efficacy and safety of palonosetron for the subjects who undergo gynecologic or simple laparoscopic surgery. As the previous studies of palonosetron evaluated only the prevention of postoperative nausea and vomiting (PONV), there was no evidence-based guideline of palonosetron for treatment of PONV. The aim of the present study is to evaluate the treatment efficacy and safety of palonosetron for the patients who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia.

Official Title
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A Randomized, Double Blind, Multicenter Phase III Trial to Evaluate the Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting

Conditions
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Laparoscopic Gynecologic, Abdominal, Other Surgery, General Anesthesia

Intervention / Treatment
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* Drug: Palonosetron
* Drug: placebo control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 years and older, younger than 70 years old American society of Anesthesiologists physical status classification I to III those who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia surgery for which anesthesia is expected to last at least 30 minutes if a subject has or may develop prolongation of cardiac conduction intervals, particularly corrected QT interval, he/she may be enrolled at the discretion of the investigator. Exclusion Criteria: known hypersensitivity/ contraindication to 5-hydroxytryptamine antagonists or study drug excipient inability to understand or cooperate with the study procedures as determined by the investigator women who are pregnant, nursing or planning to become pregnant, are not using effective birth control, or that have had a positive serum pregnancy test within 7 days prior to surgery day 1. has received any investigational drug within 30 days before study entry having taken any drug with potential antiemetic efficacy within 24 hour prior to anesthetic procedures. any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia known or suspected current history of alcohol abuse or drug abuse. any condition, which in the opinion of the investigator would make the subject ineligible for participation in the study

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: Palonsetron<br> | Drug: Palonosetron<br>* palonosetron 0.075 mg intravenous injection over 10 seconds when nausea with NRS >= 4, or developement of retching or vomiting more than one time within three hour after the end of surgery.<br>* Other names: Aloxi (palonosetron);|
| Placebo Comparator: Placebo<br> | Drug: placebo control group<br>* placebo intravenous injection over 10 seconds when nausea with NRS >= 4, or developement of retching or vomiting more than one time within three hour after the end of surgery.<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response at 24 hr | Complete response means no retching or vomiting and no administration of secondary rescue drug. | at 24 hour after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response at 72 hr | Complete response means no retching or vomiting and no administration of secondary rescue drug. | at 72 hour after randomization | 
| Complete control at 72 hr | Complete control means no retching or vomiting and no nausea with numerical rating scale >= 4 and no administration of secondary rescue drug. | at 72 hour after randomization | 
| Complete control at 24 hr | Complete control means no retching or vomiting and no nausea with numerical rating scale >= 4 and no administration of secondary rescue drug. | at 24 hour after randomization | 
| the incidence of nausea, retching, vomiting | the incidence of nausea with numerical rating scale >= 4, retching, vomiting | at 24, 48, 72 hr after randomization | 
| Time to recovery of nausea, retching, or vomiting | Time to recovery of nausea, retching, or vomiting from administration of palonosetron | at 24, 48, 72 hr after randomization | 
| the severity of nausea | the severity of nausea measured by NRS (numerical rating scale) | at the time of, 24, 48, 72 hour after randomization | 
| the incidence of rescue drug use | the incidence of rescue drug use | at 24, 48, 72 hour after randomization | 
| QOL by modified Osoba Nausea and Emesis Module | QOL by modified Osoba Nausea and Emesis Module | at 24, 48, 72 hour after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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palonosetron, postoperative nausea and vomiting