Ramosetron on Late PONV (Postoperative Nausea and Vomiting)

Phase 4

Completed

• Conditions: Postoperative Nausea and Vomiting; Breast Cancer Female
• Interventions: Drug: Ramosetron Hydrochloride

• Registration Number: NCT05326360
• Lead Sponsor: Pusan National University Hospital

Brief Summary

The purpose of this study was to evaluate the effectiveness of additional ramosetron injection for controlling late postoperative nausea and vomiting (PONV) after breast surgery in high risk PONV patients. The investigators compared PONV amomng 3 groups- group C: no additional ramosteron, group B: two additional ramosteron doses at 12 hour interval, group M: two additional ramosetron doses mix to the intraveonus patient controlled analgesia.

Detailed Description

The investigators included high risk patients of PONV with a score of 3 or more as measured by the Apfel's score and over 18 years old who receive breast surgery and intravenous patient controlled analgesia. All patients was received ramosetron 0.3 mg at the end of surgery. The patients were evaluated for number of PONV (nausea, vomiting, retching) at 1, 6, 24, and 48 hours postoperatively. Nausea was defined as an unpleasant feeling of vomiting. Retching was defined as an excessive contraction or a regular movement. of the respiratory muscles where no gastric contents were excreted, and vomiting was defined as the excretion of gastric contents. PONV were further detailed quantified using the RINVR score (Rhodes Index of Nausea, Vomiting, and Retching) which enabled the patients' objective and subjective symptoms to be evaluated as a simple and reliable methods.

Intravenous injection of ondansetron 4 mg was administered as a rescue antiemetic. The patients were evaluated 2 hours after ondansetron administration. If the symptom persisted, use of second rescue antiemetics dexamethasone 5 mg.

Study Timeline

• Study Start: 2020-12-17
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Study First Submitted: 2022-03-16
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-05
• Last Update Submitted: 2022-04-12
• Study First Posted: 2022-04-13
• Last Update Posted: 2022-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• age over 18 years
• American Society of Anesthesiologists (ASA) physical status I or II
• requesting IV PCA (patient control of analgesia) for pain control
• the high-risk group of PONV with a score of 3 or more as measured by the Apfel's score.

Exclusion Criteria

• emergency operation
• re-operation
• drug abuse, allergy
• major organ disease (gastrointestinal, cardiovascular, respiratory, cerebral, renal or hepatic disease)
• smoker
• pregnancy
• lactation
• previously use of antiemetics or systemic steroids within 48 before surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group M	Ramosetron Hydrochloride	receive ramosetron i.v. 0.3mg at the end of surgery followed ramosetron 0.6 mg mix with the patient-controlled analgesia (PCA) regimen
group B	Ramosetron Hydrochloride	receive ramosetron i.v. 0.3mg at the end of surgery with two additional doses of ramosetron at 12- and 24- hour postoperative time points

Primary Outcome Measures

Name	Time	Method
number of PONV	24hour postoperatively	number of nausea, vomiting, retching

Secondary Outcome Measures

Name	Time	Method
number of PONV	1hour, 6hour, 48 hour postoperatively	number of nausea, vomiting, retching
Rhodes Index of Nausea, Vomiting, and Retching (RINVR) score	1hour, 6hour, 24hour, 48 hour postoperatively	further detaied quantified in PONV experience, total score: 32, none:0, mild: 1-8 point, moderate: 9-16 point, great: 17-24 point, severe: 25-32 point

Trial Locations

Locations (1)

Pusan National University Hopsital; 🇰🇷 Busan, Korea, Republic of