Ramosetron on Late PONV (Postoperative Nausea and Vomiting)

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05326360
• Other study ID #: 2012-001-108
• Status: Completed
• Phase: Phase 4
• Start date: December 17, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: April 2022
• Source: Pusan National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hopsital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of PONV	number of nausea, vomiting, retching	24hour postoperatively
Secondary	number of PONV	number of nausea, vomiting, retching	1hour, 6hour, 48 hour postoperatively
Secondary	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