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

NCT ID: NCT01568268

Last Updated: 2013-12-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 384 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-06-30

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.

Conditions

Laparoscopic Gynecologic, Abdominal, Other Surgery; General Anesthesia

Keywords

palonosetron; postoperative nausea and vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Palonsetron

Group Type: EXPERIMENTAL

Palonosetron

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

placebo control group

Intervention Type: DRUG

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.

Interventions

Palonosetron

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.

Intervention Type: DRUG

placebo control group

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.

Intervention Type: DRUG

Other Intervention Names

Aloxi (palonosetron); placebo

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HK inno.N Corporation

INDUSTRY

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tae Soo Hahm, MD, PhD

Role: STUDY_DIRECTOR

Samsung Seoul Hospital, Samsung Medical Center

Youn Hong Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kangpook Samsung Hospital, Samsung Medical Center

Jung Won Hwang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Joun Heum Yeon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sange Bahk Hospital, Inje School of Medicine

Locations

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

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 25037960 (View on PubMed)

Other Identifiers

CJ_ALX_302

Identifier Type: OTHER

Identifier Source: secondary_id

2011-11-112

Identifier Type: -

Identifier Source: org_study_id