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Completed

NCT Number: NCT05326360

Ramosetron on Late PONV (Postoperative Nausea and Vomiting)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pusan National University Hopsital

Busan, 49241, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ramosetron Hydrochloride

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.

Primary outcomes

  1. number of PONV

    Time frame: 24hour postoperatively

    number of nausea, vomiting, retching

Secondary outcomes

  1. number of PONV

    Time frame: 1hour, 6hour, 48 hour postoperatively

    number of nausea, vomiting, retching

  2. Rhodes Index of Nausea, Vomiting, and Retching (RINVR) score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Pusan National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 13, 2022
Registry last updated
Apr 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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