nalgesic Efficacy and Effect on Postoperative Delirium of Oliceridine in a Multimodal Analgesia Regimen for Elderly Patients Undergoing Surgery for Hip Fracture: A Multicenter, Randomized, Double-Blind, Controlled Trial

Analgesic Efficacy and Effect on Postoperative Delirium of Oliceridine in a Multimodal Analgesia Regimen for Elderly Patients Undergoing Surgery for Hip Fracture: A Multicenter, Randomized, Double-Blind, Controlled Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600115914

Enrollment

Unknown

Registered

2026-01-04

Start date

2026-01-15

Completion date

Unknown

Last updated

2026-01-05

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

Conditions

postoperative delirium

Interventions

Sufentanil group:Administer 10 µg of sufentanil 10 minutes before the end of surgery. Postoperative sufentanil pump configuration: sufentanil 2 µg/kg, dexmedetomidine 1 µg/kg, ondansetron 10 mg, dilut

Oliceridine group:Administer 3 mg of Oxycodone 10 minutes before the end of surgery. Postoperative Oxycodone pump configuration: Oxycodone 0.5 mg/kg, Dexmedetomidine 1 µg/kg, Tropisetron 10 mg, dilute

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 65 years; 2. BMI 18.5-29.9; 3. ASA class I-III; 4. Normal preoperative cognitive function (China is still a developing country, with a large elderly population that has not received formal education. Especially in this study, the enrolled subjects are elderly patients, with many having no formal education. Therefore, according to relevant literature, an MMSE score >17 is used); 5. Patients scheduled for hip fracture surgery under general anesthesia; 6. Patients receiving postoperative patient-controlled intravenous analgesia (PCIA); 7. Able to read and write, and capable of signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Preoperative Mini-Mental State Examination (MMSE) score <= 17; 2. History of severe psychiatric or neurological disorders before surgery; 3. Unable to communicate before surgery due to cognitive or language impairments; 4. History of drug or psychotropic substance abuse before surgery; 5. Allergy to Oxycodone or Sufentanil; 6. Severe visual or hearing impairment; 7. Liver or kidney dysfunction or patients on dialysis; 8. Presence of severe cardiovascular, respiratory, or autonomic nervous system disorders; 9. Contraindications to nerve block.

Design outcomes

Primary

Measure	Time frame
Incidence of postoperative delirium from postoperative days 1 to 7.;	—

Secondary

Measure	Time frame
NRS pain score and postoperative sedation assessed by the RASS scale.;Serum inflammatory markers: IL-6, TNF-a, CRP levels.;The time from the first press of the analgesic pump to the administration of the loading dose, the number of PCA presses, and the rescue analgesic drugs and their consumption.;Incidence of adverse reactions;Postoperative hospital stay, incidence of complications during hospitalization and within 30 days after surgery;QoR-15 score;Postoperative sleep PSQI score;	—

Measure

Time frame

NRS pain score and postoperative sedation assessed by the RASS scale.;Serum inflammatory markers: IL-6, TNF-a, CRP levels.;The time from the first press of the analgesic pump to the administration of the loading dose, the number of PCA presses, and the rescue analgesic drugs and their consumption.;Incidence of adverse reactions;Postoperative hospital stay, incidence of complications during hospitalization and within 30 days after surgery;QoR-15 score;Postoperative sleep PSQI score;

—

Countries

China

Contacts

Public ContactJiaqiang Zhang

Henan Provincial People's Hospita,medical

jqzhang@henu.edu.cn+86 13937121360

Outcome results

None listed

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