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Clinical study on efficacy and safety of oxalidine fumarate injection for postoperative analgesia in elderly orthopedic patients

Clinical study on efficacy and safety of oxalidine fumarate injection for postoperative analgesia in elderly orthopedic patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108610
Enrollment
Unknown
Registered
2025-09-02
Start date
2025-09-15
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

femoral fracture

Interventions

Control group:Postoperative use of PCIA formula: 150ug of succinylsufentanil injection + 5mg of tropisetron + 150ml of 0.9% NS. Administration plan: loading dose 2ml, PCA dose 2ml/time, lockout time 1
Experimental Group 1:Postoperative use of PCIA formula: Asperigillin Maleate Injection 30mg + Tropisetron 5mg + 0.9% NS 150ml
Administration plan: Loading dose 1.5mg, PCA can be used 10 minutes after the loading dose, PCA dose 1.75ml/time, lockout time 6 minutes, continuous infusion rate: 3ml/h, 24-hour dosage not exceeding
Experimental Group 2:Postoperative use of PCIA formula: Aspirinol Maleate Injection 30mg + Tropisetron 5mg + 0.9% NS 150ml
Administration plan: Loading dose 1.5mg, PCA can be used 10 minutes after the loading dose, PCA dose 1.75ml/time, lockout time 6 minutes, continuous infusion rate: 4ml/h, total 24-hour dosage not exce

Sponsors

Mianyang 404 Hospital (The First People's Hospital Of Mianyang)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age (60 to 80 years old); 2. Gender unrestricted; 3. Body Mass Index (BMI) (18 to 32 kg/m2); 4. American Society of Anesthesiologists (ASA) classification I-III; 5. Elective unilateral hip replacement surgery; 6. General anesthesia with endotracheal intubation; 7. Before the trial, informed consent must be obtained from the subject's guardian, and a written informed consent form must be voluntarily signed.

Exclusion criteria

Exclusion criteria: Patients with severe respiratory depression, drug abuse, acute or severe bronchial asthma, drug allergy, severe cardiopulmonary dysfunction, severe liver or kidney dysfunction, a history of mental illness, and those using any illegal or prescribed drugs who are scheduled to undergo hip replacement surgery.

Design outcomes

Primary

MeasureTime frame
The satisfaction rate of pain relief as indicated by the NRS score within 48 hours after the surgery;

Secondary

MeasureTime frame
The occurrence of respiratory depression within 48 hours after the operation.;The occurrence of nausea and vomiting within 48 hours after the operation.;The occurrence rates of urinary retention, constipation and generalized itching within 48 hours after the operation.;The remedial analgesic methods and specific medication usage within 48 hours after the surgery.;

Countries

China

Contacts

Public ContactPang Xiaoyi

Mianyang 404 Hospital (The First People's Hospital Of Mianyang)

418595988@qq.com+86 152 8118 9625

Outcome results

None listed

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