A Trial of Tegileridine Fumarate Lnjection for Prolonged Mechanical Ventilation Abirritation in t… (NCT07372924) | Clinical Trial Compass
RecruitingPhase 2
A Trial of Tegileridine Fumarate Lnjection for Prolonged Mechanical Ventilation Abirritation in the Intensive Care Unit (ICU)
China120 participantsStarted 2026-02-24
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of Tegileridine Fumarate lnjection for prolonged abirritation(48h to 72h) during mechanical ventilation in the ICU.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Patients or their guardians are able to provide a written informed consent
✓. Subjects have been treated with endotracheal intubation and mechanical ventilation ≤24h, and then prolonged mechanical ventilation ≥48h in the next
✓. Age ≥ 18 and ≤ 85 years, Male or female
✓. Body mass index (BMI) \> 18 and \< 30 kg/m2
✓. Use of highly effective contraception for a specified period if applicable
Exclusion criteria
✕. Those who are known or suspected to be allergic or contraindicated to various components of the experimental drugs involved in the research institute
✕. With an expected survival time of less than 48 hours
✕. unable to undergo CPOT and RASS assessments due to various reasons, such as a history of psychiatric disorders, neurological disorders, neurological dysfunction, and consciousness disorders, as well as blindness, deafness, or aphasia
✕. Malignant tumor Subjects who received radiotherapy, chemotherapy, targeted therapy, and immunotherapy within the first month of randomization
✕. Chronic pain requires long-term use of analgesics
What they're measuring
1
Rate of abirritation success, abirritation success is defined as the percentage of time maintaining target abirritation in the entire drug administering time ≥ 70%.
Timeframe: within 3 days after administration of research drug