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NCT Number: NCT01568268

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

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.

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Key information

Conditions

Laparoscopic Gynecologic, Abdominal, Other Surgery General Anesthesia Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Samsung Medical Center, Seoul, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palonosetron

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.

Other names: Aloxi (palonosetron)

placebo control group

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.

Other names: placebo

Primary outcomes

  1. Complete response at 24 hr

    Time frame: at 24 hour after randomization

    Complete response means no retching or vomiting and no administration of secondary rescue drug.

Secondary outcomes

  1. Complete response at 72 hr

    Time frame: at 72 hour after randomization

    Complete response means no retching or vomiting and no administration of secondary rescue drug.

  2. Complete control at 72 hr

    Time frame: 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.

  3. Complete control at 24 hr

    Time frame: 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.

  4. the incidence of nausea, retching, vomiting

    Time frame: at 24, 48, 72 hr after randomization

    the incidence of nausea with numerical rating scale >= 4, retching, vomiting

  5. Time to recovery of nausea, retching, or vomiting

    Time frame: at 24, 48, 72 hr after randomization

    Time to recovery of nausea, retching, or vomiting from administration of palonosetron

  6. the severity of nausea

    Time frame: at the time of, 24, 48, 72 hour after randomization

    the severity of nausea measured by NRS (numerical rating scale)

  7. the incidence of rescue drug use

    Time frame: at 24, 48, 72 hour after randomization

    the incidence of rescue drug use

  8. QOL by modified Osoba Nausea and Emesis Module

    Time frame: at 24, 48, 72 hour after randomization

    QOL by modified Osoba Nausea and Emesis Module

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • HK inno.N Corporation

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 2, 2012
Registry last updated
Dec 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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