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The Efficacy and Safety of Tegileridine in Moderate to Severe Pain Management Following General Anesthesia in Elderly Total Hip Replacement Patients

The Efficacy and Safety of Tegileridine in Moderate to Severe Pain Management Following General Anesthesia in Elderly Total Hip Replacement Patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115758
Enrollment
Unknown
Registered
2025-12-30
Start date
2025-10-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Hip fracture

Interventions

Group Tegileridine:During induction of anesthesia, select sufentanil 0.3–0.4 µg/kg as the opioid analgesic, etomidate 0.3 mg/kg as the sedative, and rocuronium bromide 0.6 mg/kg as the muscle relaxant
propofol is discontinued approximately 10 minutes before surgery completion, with an additional bolus of 0.05 µg/kg sufentanil
remifentanil is discontinued immediately upon surgery completion. Postoperative analgesia commenced with an intravenous loading dose of 0.5 mg (2 mL) of tegilerdine. Following the loading dose, 48-hou
Group Sufentanil:During induction of anesthesia, select sufentanil 0.3–0.4 µg/kg as the opioid analgesic, etomidate 0.3 mg/kg as the sedative, and rocuronium bromide 0.6 mg/kg as the muscle relaxant.

Sponsors

Huaihe Hospital of Henan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age over 65 years old; 2. Patients scheduled for total hip replacement under general anesthesia; 3. ASA classification Grade II or III; 4. BMI 18 to 30 kg^2; 5. Able to comprehend methods for assessing pain intensity.

Exclusion criteria

Exclusion criteria: 1. Pre-existing acute or chronic pain; 2. Advanced tumors with ascites or widespread metastasis, or currently undergoing systemic chemotherapy or radiotherapy, or requiring postoperative hyperthermic perfusion; 3. Allergic to or contraindicated for anesthetics, adjuvant analgesics, rescue analgesics, antiemetics, or antibiotics used in the study; 4. Long-term treatment with opioids or use of any analgesic within 48 hours before surgery; 5. Suffering from sleep apnea syndrome; 6. Suffering from mental and neurological diseases, gastrointestinal obstruction, chronic obstructive pulmonary disease or cor pulmonale, cardiovascular diseases, etc.; 7. Oral, inhalational, or parenteral administration of corticosteroids within three months before surgery.

Design outcomes

Primary

MeasureTime frame
Response rate to the test drug at various time points within 24 hours after administration of the loading dose;

Secondary

MeasureTime frame
The proportion of patients not administered rescue analgesic medication during the treatment period;Number of supplementary analgesic administrations during the treatment period;Total number of compressions and effective compressions for the PCIA pump;Frequency of use of rescue analgesics during the treatment period;

Countries

China

Contacts

Public ContactXin Wenqi

Huaihe Hospital of Henan University

xwq_mzk@163.com+86 166 0378 1303

Outcome results

None listed

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