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Analgesic Effect, Neuroprotective Function, and Safety Evaluation of the Biased µ-Opioid Receptor Agonist Tegileridine Fumarate in Patients Undergoing Intracranial Tumor Resection: A Single-Center Randomized Controlled Non-Inferiority Trial

Analgesic Effect, Neuroprotective Function, and Safety Evaluation of the Biased µ-Opioid Receptor Agonist Tegileridine Fumarate in Patients Undergoing Intracranial Tumor Resection: A Single-Center Randomized Controlled Non-Inferiority Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104605
Enrollment
Unknown
Registered
2025-06-19
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Intracranial Tumor Resection Surgery

Interventions

Experimental Group One:After anesthesia induction and before the start of surgery, a loading dose of 0.75 mg tegileridine will be administered, followed by a patient-controlled analgesia (PCA) bolus o
Experimental Group Two:After anesthesia induction and before the start of surgery, a loading dose of 1 mg tegileridine will be administered, followed by a patient-controlled analgesia (PCA) bolus of 0
Experimental Group Three:After anesthesia induction and before the start of surgery, administer a loading dose of 0.75 mg tegileridine, followed by a patient-controlled analgesia (PCA) bolus of 0.05 m
Experimental Group Four: After anesthesia induction and before the start of surgery, administer a loading dose of 1 mg tegileridine, followed by a patient-controlled analgesia (PCA) bolus of 0.05 mg p
Control Group: After anesthesia induction and before the start of surgery, administer a loading dose of 0.3 µg sufentanil, followed by a patient-controlled analgesia (PCA) bolus of 0.2 µg per injectio

Sponsors

The Second People's Hospital of Guiyang
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1. Age> = 18 years old and < 65 years old, gender is not limited; 2. Patients with American Society of Anesthesiologists score (ASA score) grade I-II; 3. Those who have undergone craniotomy for the first time to resect intracranial tumors and have no history of radiotherapy and chemotherapy in the past; 4. Preoperative MRI showed that the tumor diameter was =40 mm; 5. Preoperative Mini-Mental State Scale (MMSE) score= 23 points; 6. Subjects or their legal representatives are able to sign the informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1. Glasgow Coma Scale (GCS) score of <15; 2. Patients with other malignant tumors; 3. Pregnancy or lactation; 4. Patients with serious underlying diseases of heart, lung, liver, kidney and other organs; 5. Patients with mental disorders who are unable to cooperate with the completion of intraoperative anesthesia assessment; 6. Patients with severe respiratory depression (oxygen saturation <90%); 7. Patients with acute or severe bronchial asthma without vital signs monitoring or vital resuscitation equipment; 8. Known or suspected gastrointestinal obstruction, including patients with paralytic intestinal obstruction; 9. Patients who are allergic to opioids and any of the ingredients of this product are prohibited; 10. Recent frequent use of analgesics, tolerance to opioids or physical dependence; 11. Participated in other clinical trials within 4 weeks before surgery; 12. Those who are considered unsuitable for enrollment by the investigator.

Design outcomes

Primary

MeasureTime frame
The sum of pain intensity differences within 24 hours after administration (SPID24) is defined as the time-weighted sum of pain intensity within 24 hours after the start of treatment.;

Secondary

MeasureTime frame
The sum of pain intensity differences within 4 hours (SPID4), 8 hours (SPID8), 12 hours (SPID12), 16 hours (SPID16), 20 hours (SPID20), and 48 hours (SPID48) after administration.;

Countries

China

Contacts

Public ContactFang Hua

The Second People's Hospital of Guiyang

succiniter@126.com+86 186 8519 3576

Outcome results

None listed

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