Ramosetron on Late PONV (Postoperative Nausea and Vomiting)
Primary Purpose
Postoperative Nausea and Vomiting, Breast Cancer Female
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ramosetron Hydrochloride
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring mastectomy, postoperative nausea and vomiting, ramosetron
Eligibility Criteria
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
Sites / Locations
- Pusan National University Hopsital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
group C
group B
group M
Arm Description
receive ramosetron i.v. 0.3mg at the end of surgery without additional ramosetron
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
receive ramosetron i.v. 0.3mg at the end of surgery followed ramosetron 0.6 mg mix with the patient-controlled analgesia (PCA) regimen
Outcomes
Primary Outcome Measures
number of PONV
number of nausea, vomiting, retching
Secondary Outcome Measures
number of PONV
number of nausea, vomiting, retching
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
Full Information
NCT ID
NCT05326360
First Posted
March 16, 2022
Last Updated
April 12, 2022
Sponsor
Pusan National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05326360
Brief Title
Ramosetron on Late PONV (Postoperative Nausea and Vomiting)
Official Title
The Effect of Additional Administration of Ramosetron on Late PONV (Postoperative Nausea and Vomiting) in Patients Undergoing Breast Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting, Breast Cancer Female
Keywords
mastectomy, postoperative nausea and vomiting, ramosetron
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group C
Arm Type
No Intervention
Arm Description
receive ramosetron i.v. 0.3mg at the end of surgery without additional ramosetron
Arm Title
group B
Arm Type
Experimental
Arm Description
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
Arm Title
group M
Arm Type
Experimental
Arm Description
receive ramosetron i.v. 0.3mg at the end of surgery followed ramosetron 0.6 mg mix with the patient-controlled analgesia (PCA) regimen
Intervention Type
Drug
Intervention Name(s)
Ramosetron Hydrochloride
Intervention Description
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.
Primary Outcome Measure Information:
Title
number of PONV
Description
number of nausea, vomiting, retching
Time Frame
24hour postoperatively
Secondary Outcome Measure Information:
Title
number of PONV
Description
number of nausea, vomiting, retching
Time Frame
1hour, 6hour, 48 hour postoperatively
Title
Rhodes Index of Nausea, Vomiting, and Retching (RINVR) score
Description
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
Time Frame
1hour, 6hour, 24hour, 48 hour postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Pusan National University Hopsital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Ramosetron on Late PONV (Postoperative Nausea and Vomiting)
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