Laparoscopic Gynecologic, Abdominal, Other Surgery, General Anesthesia
Conditions
Keywords
palonosetron, postoperative nausea and vomiting
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.
Interventions
DRUGPalonosetron
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.
Sponsors
HK inno.N Corporation
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Complete response at 72 hr | at 72 hour after randomization | Complete response means no retching or vomiting and no administration of secondary rescue drug. |
| 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 |
| 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 |
Countries
South Korea
Outcome results
None listed