Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting
- Conditions
- Laparoscopic Gynecologic, Abdominal, Other SurgeryGeneral Anesthesia
- Interventions
- Drug: placebo control group
- Registration Number
- NCT01568268
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 384
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo control group - Palonsetron Palonosetron -
- Primary Outcome Measures
Name Time Method Complete response at 24 hr at 24 hour after randomization Complete response means no retching or vomiting and no administration of secondary rescue drug.
- Secondary Outcome Measures
Name Time Method Complete response at 72 hr at 72 hour after randomization Complete response means no retching or vomiting and no administration of secondary rescue drug.
Complete control at 72 hr at 72 hour after randomization Complete control means no retching or vomiting and no nausea with numerical rating scale \>= 4 and no administration of secondary rescue drug.
Complete control at 24 hr at 24 hour after randomization Complete control means no retching or vomiting and no nausea with numerical rating scale \>= 4 and no administration of secondary rescue drug.
the incidence of nausea, retching, vomiting at 24, 48, 72 hr after randomization the incidence of nausea with numerical rating scale \>= 4, retching, vomiting
Time to recovery of nausea, retching, or vomiting at 24, 48, 72 hr after randomization Time to recovery of nausea, retching, or vomiting from administration of palonosetron
the severity of nausea at the time of, 24, 48, 72 hour after randomization the severity of nausea measured by NRS (numerical rating scale)
the incidence of rescue drug use at 24, 48, 72 hour after randomization the incidence of rescue drug use
QOL by modified Osoba Nausea and Emesis Module at 24, 48, 72 hour after randomization QOL by modified Osoba Nausea and Emesis Module
Trial Locations
- Locations (4)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Bungdang Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Kangpook Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Sangye Bahk Hospital, Inje School of Medicine
🇰🇷Seoul, Korea, Republic of