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Evaluation of the efficacy and safety of ondansetron oral film in the prevention of postoperative nausea and vomiting after primary total joint arthroplasty

Evaluation of the efficacy and safety of ondansetron oral film in the prevention of postoperative nausea and vomiting after primary total joint arthroplasty

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097588
Enrollment
Unknown
Registered
2025-02-21
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

Bone and joint disease

Interventions

Group A:Prophylactic use of ondansetron oral film is not used preoperatively.
Group B:16 mg of ondansetron oral dissolution membrane will be administered orally 1 hour before anesthesia induction.
Group C:16mg orally 1 hour before induction of anesthesia + 8mg orally 8 hours after induction of anesthesia.
Group D:8mg orally 1 hour before anesthesia induction.
Group E:8mg orally 1 hour before induction of anesthesia + 8mg orally 8 hours after induction of anesthesia.
Group F:8mg orally 1 hour before induction of anesthesia + 8mg orally 8 hours after induction of anesthesia + 8mg orally 16 hours after induction of anesthesia.

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients aged between 18 and 80 years underwent primary, unilateral hip-knee replacement for end-stage hip-knee disease.

Exclusion criteria

Exclusion criteria: (1) Ondansetron allergy; (2) Systemic use of steroids and antiemetics within 24 hours before surgery; (3) History of steroid or immunosuppressive drug use within 6 months prior to surgery; (4) A history of gastrointestinal disease, such as reflux esophagitis, gastroduodenal ulcer, or severe impairment of gastrointestinal motility; (5) Poor perioperative blood sugar and blood pressure control; (6) Combined with Meniere syndrome and other diseases that may cause nausea and vomiting; (6) Patients who are participating in other clinical studies or who are expected to have insufficient compliance.

Design outcomes

Primary

MeasureTime frame
Frequency and intensity of nausea;Frequency of vomiting;

Secondary

MeasureTime frame
Adverse reactions related to drug use;

Countries

China

Contacts

Public ContactWang Haoyang

West China Hospital of Sichuan University

wanghaoyang-scu@163.com+86 189 8060 5081

Outcome results

None listed

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