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Safety and efficacy of Tegilildine fumarate for postoperative analgesia: a multicenter, prospective real-world cohort study

Safety and efficacy of Tegilildine fumarate for postoperative analgesia: a multicenter, prospective real-world cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113874
Enrollment
Unknown
Registered
2025-12-04
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Adverse events of postoperative analgesic drugs

Interventions

Tegileridine Fumarate group:None
None-Tegileridine Fumarate group:None

Sponsors

Guangdong Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1)Age: 18 <=y<=80 years old, gender not limited; 2) ASA classification grades I - III; 3) Elective surgery is routinely performed, with no restrictions on the type of surgery; 4) No previous use of biased µ -opioid receptor agonists for analgesia; 5) Operation duration: 1 hour <= t<=6 hours; 6) The postoperative hospital stay is longer than 24 hours; 7) The patient voluntarily signs the informed consent form;

Exclusion criteria

Exclusion criteria: 1) patients with severe respiratory depression such as oxygen saturation < 90%; 2) patients with acute or severe asthma; 3) known or suspected GI obstruction, including paralytic ileus; 4) patients with allergy to opioids or any component of the trial drug; 5) pregnant or lactating women; 6) patients with mental disorders who are unable to cooperate; 7) prolonged QT interval on ECG; 8) patients with sinus bradycardia; 9) patients deemed by the investigators to be ineligible for enrollment;

Design outcomes

Primary

MeasureTime frame
The incidence of adverse events 24 hours after surgery;

Secondary

MeasureTime frame
Pian score;Rescue analgesia;

Countries

China

Contacts

Public ContactShu Haihua

Guangdong Provincial People's Hospital

shuhaihua@hotmail.com+86 134 2753 6899

Outcome results

None listed

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