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Recruiting NCT07372924

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

Phase II Interventional Abirritation in the ICU

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tegileridine Fumarate lnjection, Tegileridine Fumarate lnjection, Remifentanil Hydrochloride for Injection.
Who it may be relevant to
Registry conditions: Abirritation in the ICU. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

Interventions

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

Primary outcome measures

  • 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 outcome measures (7)
  • Percentage of time maintaining target abirritation in the entire drug administering time. [Time frame: within 3 days after administration of research drug]
  • Percentage of subjects receiving rescue analgesic drug [Time frame: within 3 days after administration of research drug]
  • The total dosage of rescue analgesic drug [Time frame: within 3 days after administration of research drug]
  • Receiving the total dosage of sedation [Time frame: within 3 days after administration of research drug]
  • Nursing Scores [Time frame: within 3 days after discontinuation of research drug]
  • Mechanical ventilation time. [Time frame: From research drug administration to actual extubation , up to 72 hours]
  • Extubation time [Time frame: From discontinuation of research drug to actual extubation , up to 72 hours]

Eligibility criteria

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
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • Zhongshan Hospital — Shanghai
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Hubei

Identifiers

NCT: NCT07372924 · SHR8554-205

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗