Clinical trial NCT01568268: Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting
Official title: A Randomized, Double Blind, Multicenter Phase III Trial to Evaluate the Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Laparoscopic Gynecologic, Abdominal, Other Surgery
General Anesthesia
Keywords: palonosetron
postoperative nausea and vomiting
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: HK inno.N Corporation
First posted: 2012-04-02
Enrollment: 384
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Complete response at 24 hr
timeFrame: at 24 hour after randomization
Secondary outcomes:
measure: Complete response at 72 hr
timeFrame: at 72 hour after randomization
measure: Complete control at 72 hr
timeFrame: at 72 hour after randomization
measure: Complete control at 24 hr
timeFrame: at 24 hour after randomization
measure: the incidence of nausea, retching, vomiting
timeFrame: at 24, 48, 72 hr after randomization
measure: Time to recovery of nausea, retching, or vomiting
timeFrame: at 24, 48, 72 hr after randomization
measure: the severity of nausea
timeFrame: at the time of, 24, 48, 72 hour after randomization
measure: the incidence of rescue drug use
timeFrame: at 24, 48, 72 hour after randomization
measure: QOL by modified Osoba Nausea and Emesis Module
timeFrame: at 24, 48, 72 hour after randomization
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Bungdang Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangpook Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Sangye Bahk Hospital, Inje School of Medicine
Study officials:
affiliation: Samsung Seoul Hospital, Samsung Medical Center
name: Tae Soo Hahm, MD, PhD
role: STUDY_DIRECTOR
affiliation: Kangpook Samsung Hospital, Samsung Medical Center
name: Youn Hong Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: Jung Won Hwang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sange Bahk Hospital, Inje School of Medicine
name: Joun Heum Yeon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hahm TS, Hwang JW, Kim WH, Oh EJ, Kim DK, Choi WJ, Kim YH, Ryu JH, Yoo BH, Yon JH. A prospective, randomized, double-blind, multicenter trial to evaluate the therapeutic efficacy and safety of palonosetron in the treatment of postoperative nausea and vomiting over a 72-h period. J Anesth. 2015 Feb;29(1):21-8. doi: 10.1007/s00540-014-1884-9. Epub 2014 Jul 19.