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The effectiveness and safety of tegileridine compared with sufentanil in acute post-operative pain: a single center cohort study

The effectiveness and safety of tegileridine compared with sufentanil in acute post-operative pain: a single center cohort study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119014
Enrollment
Unknown
Registered
2026-02-13
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

None

Interventions

Exposure Group:None
Non-Exposed Group:None

Sponsors

The Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age >=18 years and <=65 years; 2.Patients scheduled to undergo elective surgery at our hospital (including spinal surgery, gynecological hysterectomy, laparoscopic gastrocolic surgery, hip/knee arthroplasty, thoracoscopic lung surgery); 3.Patients routinely administered either Fumarate Targilidine Injection (exposed group) or Sufentanil Citrate Injection (non-exposed group) for postoperative analgesia; 4.Availability of complete and traceable clinical data (including surgical records, pain score records, medication records, adverse event records, and laboratory test results).

Exclusion criteria

Exclusion criteria: 1.Known allergy or hypersensitivity to Fumarate Targilidine, Sufentanil, or any excipients of their formulations; 2.Severe hepatic or renal insufficiency (Child-Pugh Class C or end-stage renal disease with CrCl <=30 mL/min); 3.Presence of severe cardiovascular diseases (e.g., uncontrolled grade 3 hypertension, severe arrhythmia, severe valvular heart disease); 4.Concurrent use of drugs with clinically significant interactions with the study medications (e.g., Sufentanil with potent central nervous system depressants, Targilidine with potent CYP3A inhibitors); 5.Pregnancy or lactation; 6.Psychiatric disorders or cognitive impairment that would impede cooperation with pain assessment; 7.Concurrent participation in any other clinical trial of postoperative analgesia; 8.Contraindications to Sufentanil use (e.g., myasthenia gravis, acute porphyria).

Design outcomes

Primary

MeasureTime frame
the Numeric Rating Scale;

Secondary

MeasureTime frame
Incidence and severity of adverse reactions;Discontinuation rate caused by adverse reactions;The first press of PICA and total time of pressing;Sever adverse reactions and incidence rate;Postoperative Sleeping Score;SPID24/SPID48 after moving;Use rate and dosage of rescue analgesics;the total consumption of PICA;SPID 48h at resting stage;Patient satisfaction with pain management;

Countries

China

Contacts

Public ContactJialin Sun

The Affiliated Hospital of Qingdao University

sjlsyyk-412@163.com+86 532 82912611

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026