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Completed

NCT Number: NCT01476280

Palonosetron Versus Ramosetron for the Prevention of Postoperative Nausea and Vomiting

Ramosetron and palonosetron are more recently developed 5-hydroxytryptamine type 3 receptor antagonists and this randomized double blind study was designed to compare efficacy of ramosetron and palonosetron to prevent postoperative nausea and vomiting. Investigator hypothesized that palonosetron would have stronger and longer lasting antiemetic effect compared with ramosetron and evaluated the patients for the first 48 hours after surgery.

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Key information

Conditions

Postoperative Nausea and Vomiting Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Incheon St. Mary's hospital

Incheon, 403-720, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA Physical Status 1 or 2
  • Elective gynaecological laparoscopic surgery of ≥ 1h duration

Exclusion criteria

  • Anti-emetics, steroids, or psychoactive medications within 24 h of study initiation
  • Vomiting or retching in the 24 h preceding surgery
  • Cancer chemotherapy within 4 weeks or emetogenic radiotherapy within 8 weeks before study entry
  • Ongoing vomiting from gastrointestinal disease

Treatment and study plan

Palonosetron

Drug

0.075mg immediately before induction of anesthesia

Ramosetron

Drug

0.3mg immediately before induction of anesthesia

Primary outcomes

  1. Incidence of postoperative nausea and vomiting for 48 hours after surgery

    Time frame: for 48 hours after surgery

Secondary outcomes

  1. severity of nausea for 48 hours after surgery

    Time frame: for 48 hours after surgery

Sponsors and collaborators

Lead sponsor

Incheon St.Mary's Hospital

Other

Registry information

Official study title

A Randomized Double Blind Study to Evaluate Efficacy of Ramosetron and Palonosetron for Prevention of Postoperative Nausea and Vomiting After Gynaecological Laparoscopic Surgery

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 22, 2011
Registry last updated
Nov 22, 2011

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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