Tegileridine Fumarate injection for prolonged ICU agitation during mechanical ventilation

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)

This trial tests whether Tegileridine Fumarate injection can reduce prolonged agitation (48–72 hours) in adults on mechanical ventilation in the ICU.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT07372924 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study enrolls adults who have been intubated and are expected to require prolonged mechanical ventilation (48–72 hours) to receive Tegileridine Fumarate injection, with remifentanil listed among the interventions per protocol. Participants must be 18–85 years old, have a BMI between 18 and 30 kg/m2, and be able to provide informed consent or have a legal guardian provide consent. Ability to undergo bedside assessments such as CPOT and RASS is required, and those unable to be assessed are excluded. The trial will monitor measures of agitation/sedation, duration of mechanical ventilation, and safety outcomes over the treatment period.

Who should consider this trial

Good fit: Ideal candidates are adults (18–85 years) recently intubated who are expected to require mechanical ventilation for 48 hours or more, have BMI 18–30 kg/m2, and can undergo CPOT/RASS assessments and provide consent or have a proxy consent.

Not a fit: Patients who are allergic to study drugs, have expected survival under 48 hours, cannot be assessed with CPOT/RASS due to neurologic or psychiatric conditions, or have contraindicated comorbidities such as myasthenia gravis may not benefit from participation.

Why it matters

Potential benefit: If effective, Tegileridine could shorten or lessen episodes of prolonged agitation during ventilation, potentially reducing ventilation time and related complications.

How similar studies have performed: Opioids and sedatives like remifentanil have been used to manage ICU agitation, but Tegileridine is a novel investigational agent with limited published human efficacy data to date.

Eligibility criteria

Inclusion Criteria:

1. Patients or their guardians are able to provide a written informed consent
2. Subjects have been treated with endotracheal intubation and mechanical ventilation ≤24h, and then prolonged mechanical ventilation ≥48h in the next
3. Age ≥ 18 and ≤ 85 years, Male or female
4. Body mass index (BMI) \> 18 and \< 30 kg/m2
5. Use of highly effective contraception for a specified period if applicable

Exclusion Criteria:

1. Those who are known or suspected to be allergic or contraindicated to various components of the experimental drugs involved in the research institute
2. With an expected survival time of less than 48 hours
3. 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
4. Myasthenia gravis, bronchial asthma attack, acute intestinal obstruction, abdominal compartment syndrome
5. Multiple organ failure
6. Malignant tumor Subjects who received radiotherapy, chemotherapy, targeted therapy, and immunotherapy within the first month of randomization
7. Chronic pain requires long-term use of analgesics
8. Severe liver dysfunction
9. Severe renal dysfunction
10. Severe renal dysfunction
11. Need to receive deep sedation or use neuromuscular blocking drugs
12. Surgery or tracheotomy may be required during the study administration period
13. Used monoamine oxidase inhibitors within the two weeks randomization
14. 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
15. QTc abnormality during screening period
16. Positive result for infectious disease
17. Positive screening for drug abuse
18. Pregnant or nursing women;
19. Subjects who has Participated in any other clinical trials within the first 3 months of randomization
20. Other conditions deemed unsuitable to be included.

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Zhongshan Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Hubei, Wuhan, China (Recruiting)

Study contacts

• Study coordinator: Lei Tang

Conditions Abirritation in the ICU