About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Myasthenia gravis, bronchial asthma attack, acute intestinal obstruction, abdominal compartment syndrome
Trial design
Parallel
Treatments tested in this trial
Tegileridine Fumarate lnjection
DrugTegileridine Fumarate lnjection; low dose
Tegileridine Fumarate lnjection
DrugTegileridine Fumarate lnjection; high dose
Remifentanil Hydrochloride for Injection
DrugRemifentanil Hydrochloride for Injection
Treatment groups
Trial outcomes
Primary outcomes
Rate of abirritation success, abirritation success is defined as the percentage of time maintaining target abirritation in the entire drug administering time ≥ 70%.
Secondary outcomes
Percentage of time maintaining target abirritation in the entire drug administering time.
Percentage of subjects receiving rescue analgesic drug
The total dosage of rescue analgesic drug
Receiving the total dosage of sedation
Sponsors and contacts
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