Phase II Study to Evaluate Safety and Effectiveness of Tegileridine Fumarate Injection for Long-Term Pain Relief During Mechanical Ventilation in ICU

What this Trial Is About

Researchers are evaluating the effectiveness and safety of Tegileridine Fumarate Injection for managing prolonged abirritation lasting 48 to 72 hours in patients receiving mechanical ventilation in the intensive care unit ICU. This Phase II, randomized, single-blind study compares different doses of Tegileridine Fumarate Injection with Remifentanil Hydrochloride for Injection as a positive comparator, aiming to better support patients during extended ventilation periods. Participants are randomly assigned to one of three groups low dose Tegileridine Fumarate Injection, high dose Tegileridine Fumarate Injection, or Remifentanil Hydrochloride for Injection. The study explores dose levels and monitors responses over the drug administration period, which lasts up to three days. The trial takes place across multiple centers and includes a single-blind design to assess safety and efficacy. During the study, participants will be closely monitored for their ability to maintain target abirritation, use of rescue analgesic drugs, sedation levels, nursing scores, and the timing of mechanical ventilation and extubation. Outcomes are measured within 72 hours after drug administration. The study involves detailed assessments to understand treatment impact and ensure participant safety, with the total participation period lasting up to three days post-treatment.

A Trial of Tegileridine Fumarate Lnjection for Prolonged Mechanical Ventilation Abirritation in the Intensive Care Unit (ICU)