Phase 4
Completed N=142
Additional Anti-emetic Effect of Ramosetron Prophylaxis After Total Knee Arthroplasty
Osteoarthritis, Knee
Source: ClinicalTrials.gov NCT01102491 ↗
Enrolled (actual)
142
Serious AEs
36.6%
Results posted
May 2010
Primary outcomePrimary: Incidence of Nausea and Vomiting — 25; 32 participants — p=<0.05
Summary
The purposes of this study are to document the antiemetic efficacy of multimodal antiemetic protocol in patient after Total Knee Arthroplasty using regional anesthesia, midazolam & propofol, hydration & oxygen supplement, preemptive & multimodal contemporary pain management and to determine whether Ramosetron prophylaxis would provide additional antiemetic effect on this protocol. We hypothesized that the incidence of Postoperative nausea and vomiting during multimodal antiemetic protocol would be lower than Apfel's expected postoperative nausea and vomiting incidence. It was also hypothesized that Ramosetron prophylaxis would provide additional antiemetic effect.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Nausea and Vomiting |
25; 32 | <0.05 sig |
| SECONDARY Incidence of Rescue Antiemetic Administration |
— | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of primary osteoarthritis, knee
- Scheduled for elective total knee arthroplasty
- Signed written informed consent
Exclusion Criteria
- Refusing participate
- Contraindication to regional anesthesia
- Severe impairment of bowel motility
- administration of other antiemetics within 24hours before surgery
- systemic steroid within 24hours before surgery
- history of cardiovascular & respiratory disease
- renal & hepatic failure
Data sourced from ClinicalTrials.gov (NCT01102491). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.