Nausea and vomiting following initial unilateral total hip or total knee arthroplasty, including postoperative nausea, retching, vomiting, and the severity of nausea.
Conditions
Interventions
Control group:Node 1: Isotonic 0.9% saline intravenous injection
Node 2: Dexamethasone 10 mg IV
Node 3: Isotonic 0.9% saline intravenous injection
Routine prevention group:Node 1: Saline
Node 3: Ondansetron 8 mg IV
Enhanced prevention group:Node 1: Pyridoxine 0.2 g IV
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 40–80 years; 2. Scheduled for elective primary unilateral THA or TKA; 3. ASA classification I–III; 4. Able to understand the study procedures and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Known allergy to pyridoxine, dexamethasone, ondansetron, or any of their excipients; 2. Use of antiemetic drugs or systemic corticosteroids within 24 hours before surgery; 3. Long-term treatment with immunosuppressive agents or systemic corticosteroids; 4. Presence of significant gastrointestinal organic disease or severe gastrointestinal motility disorders; 5. Severe hepatic or renal dysfunction (e.g., eGFR <30 mL/min/1.73 m^2 or Child–Pugh class C); 6. Known prolonged QT interval or history of severe cardiac arrhythmia; 7. Pregnant or breastfeeding women; 8. Any other condition considered unsuitable for study participation by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postoperative nausea and vomiting (PONV) within 0–24 hours after surgery;Incidence of postoperative nausea and vomiting (PONV) within 0–48 hours after surgery;Severity of nausea within 0–24 hours after surgery (peak VAS/NRS or mean value); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of nausea in stratified time periods;Incidence and frequency of vomiting/gagging in stratified time periods;Proportion of rescue antiemetic use, time to first rescue, and cumulative dose;Time to first oral intake;Pain score and opioid consumption (morphine equivalent) at 48 hours after surgery;Interleukin-6 (IL-6) and C-reactive protein (CRP);Patient satisfaction with discharge (0–10 scale); | — |
Countries
China
Contacts
Public ContactZhou Zongke
West China Hospital of Sichuan University
Outcome results
None listed