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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
384
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.
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.
Samsung Medical Center
Seoul, Seoul, South Korea
Bungdang Seoul National University Hospital
Seoul, South Korea
Kangpook Samsung Hospital
Seoul, South Korea
Sangye Bahk Hospital, Inje School of Medicine
Seoul, South Korea
Complete response at 24 hr
Complete response means no retching or vomiting and no administration of secondary rescue drug.
Time frame: at 24 hour after randomization
Complete response at 72 hr
Complete response means no retching or vomiting and no administration of secondary rescue drug.
Time frame: 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.
Time frame: 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.
Time frame: at 24 hour after randomization
the incidence of nausea, retching, vomiting
the incidence of nausea with numerical rating scale \>= 4, retching, vomiting
Time frame: 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
Time frame: at 24, 48, 72 hr after randomization
the severity of nausea
the severity of nausea measured by NRS (numerical rating scale)
Time frame: at the time of, 24, 48, 72 hour after randomization
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the incidence of rescue drug use
the incidence of rescue drug use
Time frame: at 24, 48, 72 hour after randomization
QOL by modified Osoba Nausea and Emesis Module
QOL by modified Osoba Nausea and Emesis Module
Time frame: at 24, 48, 72 hour after randomization