Palonosetron Versus Ramosetron for the Prevention of Postoperative Nausea and Vomiting

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01476280
• Other study ID #: OC11MISI0027
• Status: Completed
• Phase: N/A
• First received: November 15, 2011
• Last updated: November 17, 2011
• Start date: May 2011
• Est. completion date: August 2011

Study information

• Verified date: November 2011
• Source: Incheon St.Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• palonosetron
0.075mg immediately before induction of anesthesia
• Ramosetron
0.3mg immediately before induction of anesthesia

Locations

Country	Name	City	State
Korea, Republic of	Incheon St. Mary's hospital	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Incheon St.Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative nausea and vomiting for 48 hours after surgery		for 48 hours after surgery	No
Secondary	severity of nausea for 48 hours after surgery		for 48 hours after surgery	No