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Evaluation of the safety and effectiveness of oliceridine (TRV130), a G-protein selective agonist at the µ-opioid receptor, and sufentanil for postoperative analgesia in elderly patients undergoing knee arthroplasty: a randomized controlled trial

Evaluation of the safety and effectiveness of oliceridine (TRV130), a G-protein selective agonist at the µ-opioid receptor, and sufentanil for postoperative analgesia in elderly patients undergoing knee arthroplasty: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099271
Enrollment
Unknown
Registered
2025-03-20
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

End-stage knee disease

Interventions

TRV130 group (group A) :TRV130 group was formulated as: 0.2 mg/kg TRV130 + ondansetron 8 mg + flurbiprofenate 200 mg + saline to 100 ml.
Sufentanil group (group B):sufentanil group was formulated as: 2 µg/kg sufentanil + ondansetron 8 mg + flurbiprofen ester 200 mg + saline to The first loading dose was 1 µg, the background dose was 2

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1 Age >= 65 years old; 2 American Society of Anesthesiologists classification ? - ?; 3 Patients with normal orientation and can correctly express their wishes; ? Body mass index 19.0 - 30.0 kg/m2; ? Patients undergoing elective hip arthroplasty.

Exclusion criteria

Exclusion criteria: (i) patient refusal; (ii) opioid addiction; (iii) long-term use of analgesic drugs; (iv) severe abnormalities in liver and kidney function; (v) previous history of vestibular dysfunction or dizziness, nausea, dry heaves, and vomiting within 1 week prior to enrollment; (vi) contraindications to the drugs to be used in the trial; (vii) participation in a trial of other drugs within 30 days prior to enrollment; (viii) history of obstructive sleep apnea syndrome; (ix) alcohol within three years,history of alcohol, drug or medication withdrawal within three years

Design outcomes

Primary

MeasureTime frame
Difference in NRS time-weighted pain intensity scores at rest during the 48-h treatment period;

Secondary

MeasureTime frame
1 h, 2 h, 4 h, 8 h, 12 h, and 24 h resting and locomotor state SPIDs;1 h, 2 h, 4 h, 8 h, 12 h, 24 h and 48 h NRS difference;Percentage of patients receiving emergency analgesic medication within 48 h postoperatively and time to first use of emergency analgesic medication;Total number of PCA pump compressions and effective compressions in 48 h;Incidence of adverse gastrointestinal reactions and percentage of patients experiencing vomiting or using emergency antiemetic drugs;

Countries

China

Contacts

Public ContactZhang hui

Shanghai Sixth People's Hospital

zhanghui12179@163.com+86 189 3017 3683

Outcome results

None listed

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