New drug aims to ease discomfort for ventilator patients in ICU
NCT ID NCT07372924
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This study tests a new sedative called tegileridine fumarate in 120 ICU patients who need a breathing machine for at least two days. The goal is to see if it keeps patients comfortable and calm better than a standard sedative. Researchers will measure how often the drug works and check for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tegileridine fumarate injection
- What this could lead to
- If it works, this could provide a new option to keep ICU patients comfortable and calm while on a breathing machine.
- What could go wrong
- This is an early Phase 2 study with only 120 people, so results may not apply to everyone. The drug may not work better than existing sedatives or could have side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
121 people
The number who actually took part.
- Started
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Feb 2026
- Finished
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Aug 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 85 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hubei, Wuhan, 430015, China
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Zhongshan Hospital
Shanghai, Shanghai Municipality, 200030, China