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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorJiangsu HengRui Medicine Co., Ltd.

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Tegileridine Fumarate lnjection

    Drug

    Tegileridine Fumarate lnjection; low dose

  • Tegileridine Fumarate lnjection

    Drug

    Tegileridine Fumarate lnjection; high dose

  • Remifentanil Hydrochloride for Injection

    Drug

    Remifentanil Hydrochloride for Injection

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Treatment group A: Tegileridine Fumarate lnjectionExperimental treatment 1 intervention
Group B: Treatment group B: Tegileridine Fumarate lnjectionExperimental treatment 1 intervention
Group C: Treatment group C: Remifentanil Hydrochloride for InjectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of abirritation success, abirritation success is defined as the percentage of time maintaining target abirritation in the entire drug administering time ≥ 70%.

Time frame
within 3 days after administration of research drug

Secondary outcomes

1

Percentage of time maintaining target abirritation in the entire drug administering time.

Time frame
within 3 days after administration of research drug
2

Percentage of subjects receiving rescue analgesic drug

Time frame
within 3 days after administration of research drug
3

The total dosage of rescue analgesic drug

Time frame
within 3 days after administration of research drug
4

Receiving the total dosage of sedation

Time frame
within 3 days after administration of research drug

Other outcomes

Sponsors and contacts

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