Efficacy Study of Antiemetics to Reduce Postoperative Nausea and Vomiting

Phase 2

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: Ramosetron

• Registration Number: NCT01806948
• Lead Sponsor: Seoul National University Hospital

Brief Summary

We randomized patients who received laparoscopic surgery for benign gynecologic disease into double dose (Experimental Group) or single dose (Control Group) of antiemetics. We compared the degree of postoperative nausea and vomiting in experimental and control groups.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-06
• Study First Submitted QC: 2013-03-06
• Study First Posted: 2013-03-07
• Study Start: 2013-04
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-19
• Last Update Posted: 2016-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

Inclusion Criteria

• Laparoscopy for benign gynecologic disease

Exclusion Criteria

• Vomiting within 24 hours before surgery
• Not using patient controlled analgesics postoperatively

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Ramosetron	Double dose of antiemetics. Specifically, Ramosetron 0.3 mg will be intravenously injected when surgery is ended. Additionally, Ramosetron 0.3 mg will be intravenously injected at 4 hours after surgery.
Control	Ramosetron	Single dose of antiemetics. Specifically, Ramosetron 0.3 mg will be intravenously injected when surgery is ended. Additionally, placebo will be intravenously injected at 4 hours after surgery.

Primary Outcome Measures

Name	Time	Method
Complete Response Rate	Postoperative 24 hours	The percentage of patients who experienced neither nausea nor vomiting within 24 hours after surgery

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam Si, Gyeonggi Do, Korea, Republic of