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

Официальное название

A Phase II, Multicenter, Randomized, Single-Blind, Dose Exploration, Positive Comparator Study to Evaluate the Efficacy and Safety of Tegileridine Fumarate Lnjection for Prolonged Mechanical Ventilation Abirritation in the Intensive Care Unit (ICU)

Обзор

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.

Вмешательства

• Препарат Tegileridine Fumarate lnjection
  Tegileridine Fumarate lnjection; low dose
• Препарат Tegileridine Fumarate lnjection
  Tegileridine Fumarate lnjection; high dose
• Препарат Remifentanil Hydrochloride for Injection
  Remifentanil Hydrochloride for Injection

Первичные конечные точки

• Rate of abirritation success, abirritation success is defined as the percentage of time maintaining target abirritation in the entire drug administering time ≥ 70%. [Срок оценки: within 3 days after administration of research drug]

Вторичные конечные точки (7)

• Percentage of time maintaining target abirritation in the entire drug administering time. [Срок оценки: within 3 days after administration of research drug]
• Percentage of subjects receiving rescue analgesic drug [Срок оценки: within 3 days after administration of research drug]
• The total dosage of rescue analgesic drug [Срок оценки: within 3 days after administration of research drug]
• Receiving the total dosage of sedation [Срок оценки: within 3 days after administration of research drug]
• Nursing Scores [Срок оценки: within 3 days after discontinuation of research drug]
• Mechanical ventilation time. [Срок оценки: From research drug administration to actual extubation , up to 72 hours]
• Extubation time [Срок оценки: From discontinuation of research drug to actual extubation , up to 72 hours]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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
• Multiple organ failure
• 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
• Severe liver dysfunction
• Severe renal dysfunction
• Severe renal dysfunction
• Need to receive deep sedation or use neuromuscular blocking drugs
• Surgery or tracheotomy may be required during the study administration period
• Used monoamine oxidase inhibitors within the two weeks randomization
• History of drug abuse, drug use, alcohol abuse, and long-term use of psychotropic drugs within 2 years prior to the start of the screening period
• QTc abnormality during screening period
• Positive result for infectious disease
• Positive screening for drug abuse
• Pregnant or nursing women;
• Subjects who has Participated in any other clinical trials within the first 3 months of randomization
• Other conditions deemed unsuitable to be included.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Zhongshan Hospital — Шанхай
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Hubei

Идентификаторы

NCT: NCT07372924 · SHR8554-205

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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