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A clinical study on the effect of Oselidine on optimizing perioperative treatment and postoperative outcome

Clinical study on the G-protein-biased µ opioid receptor agonist oxalidine for optimal analgesia after general anesthesia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094524
Enrollment
Unknown
Registered
2024-12-24
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

pain outcome

Interventions

S group:Sufentanil group treatment regimen: sufentanil 2µg· kg-1 + dexmedetomidine 1µg· kg-1 + tropisetron 10mg, mixed to 100ml with normal saline. PCIA was set to 2ml/h for continuous infusion, 2ml f
O group:Oceridine 0.2mg· kg-1 + dexmedetomidine 1µg· kg-1 + tropisetron 10mg, mixed to 100ml with normal saline. PCIA was set to 2 ml/h for continuous infusion, 2 ml for a single dose, and the locking

Sponsors

Henan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age> 65 years old; 2) ASA LEVEL I.- III; 3)BMI 18.5-29.9; 4) Patients who intend to undergo lower knee resurfacing under general anesthesia; 5) Receiving postoperative patient-controlled intravenous analgesic pump (PCIA) therapy; 6) Ability to read and write; 7) Informed consent can be signed.

Exclusion criteria

Exclusion criteria: 1) Chronic pain or mental illness before surgery; 2) Preoperative inability to communicate due to cognitive dysfunction or language impairment; 3) Patients with opioid use 3 days before surgery; 4) Patients with chronic alcohol consumption; 5) Apnea or STOP-Bang score >=3 points; 6) Subjects with abnormal liver and kidney function or dialysis; 7) Severe cardiovascular, respiratory and autonomic neuropathy; 8) Participated in clinical studies of other drugs or medical devices in the past 3 months.

Design outcomes

Primary

MeasureTime frame
SPID-48;

Secondary

MeasureTime frame
The drug consumption in the analgesic pump was recorded 48 hours after operation;The time of first pressure on the analgesic pump (the time from the patient's first pressure on the analgesic pump to the amount of load given);PCA press times;Adverse reactions 48 hours after surgery: nausea, vomiting, dizziness, headache, constipation, itching and hypoxia;Patient's postoperative sleep quality score;Cognitive Emotion-Related Indicators (3D-CAM);Patient recovery quality score, postoperative hospital stay, satisfaction;The proportion and frequency of salvage analgesia at 48 hours after surgery;Proportion of patients receiving antiemetic rescue at 48 hours postoperatively;The time of the patient's first ambulation;

Countries

China

Contacts

Public ContactZhang Jiaqiang

Henan Provincial People's Hospital

hnmzxh@163.com+86 191 3918 7667

Outcome results

None listed

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