Ramosetron on Late PONV (Postoperative Nausea and Vomiting)

Sponsor

Pusan National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05326360

Collaborator

(none)

144

Enrollment

Location

Arms

10.4

Actual Duration (Months)

13.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea and Vomiting Breast Cancer Female	Drug: Ramosetron Hydrochloride	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 17, 2020

Actual Primary Completion Date :

Oct 31, 2021

Actual Study Completion Date :

Oct 31, 2021

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

number of PONV [24hour postoperatively]
number of nausea, vomiting, retching

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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