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Comparison of efficacy between Tegillidine and Sufentanil in patient-controlled analgesia following knee replacement: A randomized double-blind controlled study.

Comparison of efficacy between Tegillidine and Sufentanil in patient-controlled analgesia following knee replacement: A randomized double-blind controlled study.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109954
Enrollment
Unknown
Registered
2025-09-28
Start date
2025-10-10
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Knee Replacement

Interventions

Sufentanil group:Sufentanil was given for PCIA.
Low-dose tegoridine group:A low dose of Tegillidine was given for PCIA.
High-dose tegoridine group:A high dose of Tegillidine was given for PCIA.

Sponsors

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years old, including cut-off values, gender is not limited; 2. Elective general anesthesia descending unilateral knee arthroplasty; 3. American Society of Anesthesiologists (ASA) rating I-III; 4. Able to understand pain intensity assessment methods; 5. Subjects understand the purpose and steps of this trial, voluntarily participate in this trial, and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Undergoing any clinical trial within 28 days before surgery; 2. Body mass index (BMI) 30 kg/m^2; 3. Allergy to opioids; 4. Allergy or contraindication to anesthesia, adjuvant analgesia, salvage analgesics, rescue antiemetics, antibiotics used in the study; 5. History of acute and chronic bronchial asthma; 6. Diagnosis or suspicion of sleep apnea syndrome; 7. Long-term opioid therapy; 8. Use of any painkillers before surgery; or long-term NSAIDs; 9. Use of drugs that affect analgesic response before surgery; 10. Abnormal liver and kidney function; 11. Prolongation of the Q-T interval of electrocardiogram; 12. Patients will be excluded if they have psychiatric or neurological diseases, gastrointestinal obstruction, chronic obstructive pulmonary disease, or pulmonary heart disease, and cardiovascular disease.

Design outcomes

Primary

MeasureTime frame
SPID;

Secondary

MeasureTime frame
Proportion of subjects who did not receive remedial analgesic treatment during the treatment period;Total dose of remedial analgesic drugs received during the treatment period;PCIA pump press total times and effective press times;

Countries

China

Contacts

Public ContactLu Yi

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

luyi1111.cool@163.com+86 577 8567 6879

Outcome results

None listed

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