Ramosetron on Late PONV (Postoperative Nausea and Vomiting)

NCT ID: NCT05326360

Last Updated: 2022-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-17
• Study Completion Date: 2021-10-31

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.

Conditions

Postoperative Nausea and Vomiting; Breast Cancer Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

group C

receive ramosetron i.v. 0.3mg at the end of surgery without additional ramosetron

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Ramosetron Hydrochloride

Intervention Type: DRUG

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.

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

Group Type: EXPERIMENTAL

Ramosetron Hydrochloride

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pusan National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eunsoo Kim

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pusan National University Hopsital

Busan, , South Korea

Countries

South Korea

Other Identifiers

2012-001-108

Identifier Type: -

Identifier Source: org_study_id