Skip to content

Clinical Study of Fumarate Oseltidine Injection for Patient-Controlled Analgesia Following Hip Replacement Surgery in Elderly Patients

Clinical Study of Fumarate Oseltidine Injection for Patient-Controlled Analgesia Following Hip Replacement Surgery in Elderly Patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093014
Enrollment
Unknown
Registered
2024-11-27
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Hip replacement

Interventions

Experimental Group (Oseltidine Group):A loading dose was administered 20 minutes before the end of surgery. In the experimental group, 1.5 mg of Oseltidine was given via intravenous injection, followe
Control Group (Hydromorphone Group):Control Group (Hydromorphone Group): A loading dose was administered 20 minutes before the end of surgery. In the control group, 0.8 mg of hydromorphone was given v

Sponsors

People's Hospital of Jizhou District, Tianjin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Signed informed consent form; (2) Patient classified as ASA I–III; (3) Age 65–85 years; (4) Use of PCIA for postoperative analgesia; (5) Basic liver and kidney function within normal range; (6) Commitment to comply with the study protocol and participate throughout the entire study.

Exclusion criteria

Exclusion criteria: (1) Presence of severe comorbidities, such as significant cardiopulmonary insufficiency or abnormal liver and kidney function; (2) Recent use of sedative drugs within the past week; (3) Known allergy to opioids; (4) History of severe dependence on anesthetic drugs or substance abuse; (5) ASA classification of IV; (6) Cognitive impairment or mental illness; (7) Patients unwilling to participate in follow-up; (8) Current participation in other clinical studies.

Design outcomes

Primary

MeasureTime frame
NRS score;Area Under the Curve (AUC) for NRS (Static/Dynamic);;Incidence of moderate to severe pain within 48 hours after surgery;

Secondary

MeasureTime frame
Analgesic relief rate within 24h and 48h after loading dose;PCA press times;Amount of opioid medication used;Quality of recovery at day 1 and day 3 after surgery (QoR-15 scale).;

Countries

China

Contacts

Public ContactYandong Huang

People's Hospital of Jizhou District, Tianjin

714457484@qq.com+86 135 1612 6818

Outcome results

None listed

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