Ramosetron on Late PONV (Postoperative Nausea and Vomiting)

The Effect of Additional Administration of Ramosetron on Late PONV (Postoperative Nausea and Vomiting) in Patients Undergoing Breast Surgery

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea and Vomiting; Breast Cancer Female
• Intervention / Treatment: Drug: Ramosetron Hydrochloride

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 Type: Interventional
• Enrollment (Actual): 144
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Pusan National University Hopsital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: group C; receive ramosetron i.v. 0.3mg at the end of surgery without additional ramosetron
EXPERIMENTAL: group B; 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	Drug: Ramosetron Hydrochloride; we injected two additional remosetron doses in different way in experimental groups. In group B, patients received additional ramosetron at 12 hour interval, in group M, patients received additional ramosetron in mixed with the patient controlled analgesia regimen.
EXPERIMENTAL: group M; receive ramosetron i.v. 0.3mg at the end of surgery followed ramosetron 0.6 mg mix with the patient-controlled analgesia (PCA) regimen	Drug: Ramosetron Hydrochloride; we injected two additional remosetron doses in different way in experimental groups. In group B, patients received additional ramosetron at 12 hour interval, in group M, patients received additional ramosetron in mixed with the patient controlled analgesia regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of PONV	number of nausea, vomiting, retching	24hour postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of PONV	number of nausea, vomiting, retching	1hour, 6hour, 48 hour postoperatively
Rhodes Index of Nausea, Vomiting, and Retching (RINVR) score	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	1hour, 6hour, 24hour, 48 hour postoperatively

Collaborators and Investigators

• Sponsor: Pusan National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 17, 2020
• Primary Completion (ACTUAL): October 31, 2021
• Study Completion (ACTUAL): October 31, 2021

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (ACTUAL): April 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: mastectomy; ramosetron; postoperative nausea and vomiting
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Serotonin Agents; Serotonin Antagonists; Ramosetron
• Other Study ID Numbers: 2012-001-108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No