Actively Recruiting
A Trial of Tegileridine Fumarate Lnjection for Prolonged Mechanical Ventilation Abirritation in the Intensive Care Unit (ICU)
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-03-13
120
Participants Needed
2
Research Sites
18 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trial of Tegileridine Fumarate Lnjection for Prolonged Mechanical Ventilation Abirritation in the Intensive Care Unit (ICU)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients or their guardians can provide written informed consent
- Have been treated with endotracheal intubation and mechanical ventilation for at least 24 hours
- Expected to require prolonged mechanical ventilation for at least 48 hours thereafter
- Age between 18 and 85 years, male or female
- Body mass index (BMI) greater than 18 and less than 30 kg/m2
- Use of highly effective contraception if applicable
You will not qualify if you...
- Known or suspected allergy or contraindication to components of the study drugs
- Expected survival time less than 48 hours
- Unable to undergo CPOT and RASS assessments due to psychiatric, neurological, or sensory disorders
- History of myasthenia gravis, bronchial asthma attack, acute intestinal obstruction, or abdominal compartment syndrome
- Multiple organ failure
- Malignant tumor with recent radiotherapy, chemotherapy, targeted therapy, or immunotherapy within one month
- Chronic pain requiring long-term analgesic use
- Severe liver dysfunction
- Severe renal dysfunction
- Need for deep sedation or neuromuscular blocking drugs
- Potential need for surgery or tracheotomy during the study period
- Use of monoamine oxidase inhibitors within two weeks before randomization
- History of drug abuse, alcohol abuse, or long-term use of psychotropic drugs within two years
- QTc abnormality during screening
- Positive test for infectious disease
- Positive screening for drug abuse
- Pregnant or nursing women
- Participation in other clinical trials within three months prior to randomization
- Other conditions deemed unsuitable for inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
2
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hubei, Wuhan, China, 430015
Actively Recruiting
Research Team
L
Lei Tang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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