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Efficacy and safety of orally soluble pellicles of ondansetron in preventing nausea and vomiting after total joint arthroplasty

Efficacy and safety of orally soluble pellicles of ondansetron in preventing nausea and vomiting after total joint arthroplasty

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088859
Enrollment
Unknown
Registered
2024-08-28
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

knee osteoarthritis

Interventions

Orally soluble pellicles (OSP) of ondansetron: Patients in the OSP ondansetron group (Group 2) received 16mg ondansetron at 1 hour before anesthesia induction, and 8mg twice daily on postoperative day
intravenous ondansetron:Patients in the IV ondansetron group (Group 3) received 8mg ondansetron at anesthesia induction and 8mg once daily on postoperative day 1 and 2.

Sponsors

West China Hospital,SCU
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients aged 40 to 80 years who received their first unilateral TJA for primary hip or knee osteoarthritis were enrolled in the trial.

Exclusion criteria

Exclusion criteria: The exclusion criteria were any one of the following: (1) history of allergy to study drugs, (2) use of systemic steroids or antiemetics within 24 hours preoperative, (3) a history of steroid or immunosuppressive drug use within the first 6 months, (4) a history of gastrointestinal disease, such as reflux esophagitis, gastroduodenal ulcer, or severe impairment of gastrointestinal motility, (5) poor control of blood glucose and blood pressure; (6) Combining other diseases such as Meniere syndrome that may cause nausea and vomiting; (7) participating in other trials or is expected to have insufficient compliance.

Design outcomes

Primary

MeasureTime frame
postoperative nausea and vomiting;

Secondary

MeasureTime frame
inflammatory biomarkers;the dosage of metoclopramide;the dosage of tramadol;common adverse drug reactions (ADRs) associated with serotonin receptor antagonists, namely pruritus, dizziness, headache, cardiac arrhythmias, and extrapyramidal signs;

Countries

China

Contacts

Public ContactJinwei XIe

West China Hospital,SCU

rain_xjw@yeah.net+86 189 8060 3029

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026