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New treatment option for Abirritation in the ICU
Official title A Trial of Tegileridine Fumarate Lnjection for Prolonged Mechanical Ventilation Abirritation in the Intensive Care Unit (ICU)
ClinicalTrials.gov ID: NCT07372924
What this study is testing
What is Tegileridine Fumarate lnjection?
Tegileridine Fumarate lnjection is an investigational medicine, being studied as a potential treatment for abirritation in the icu.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Patients or their guardians are able to provide a written informed consent
- people 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
You likely can't join if
- 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...
- Myasthenia gravis, bronchial asthma attack, acute intestinal obstruction, abdominal compartment syndrome
- Multiple organ failure
- Malignant tumor people who received radiotherapy, chemotherapy, targeted therapy, and immunotherapy within the first month of randomization
See the full eligibility criteria
- Patients or their guardians are able to provide a written informed consent
- people 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
- 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...
- Myasthenia gravis, bronchial asthma attack, acute intestinal obstruction, abdominal compartment syndrome
- Multiple organ failure
- Malignant tumor people 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;
- people who has Participated in any other clinical trials within the first 3 months of randomization
- Other conditions deemed unsuitable to be included.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
- Hubei, Wuhan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China; Hubei, Wuhan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.