Abirritation in the ICU
Conditions
Brief summary
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
DRUGTegileridine Fumarate lnjection
Tegileridine Fumarate lnjection; low dose
DRUGRemifentanil Hydrochloride for Injection
Remifentanil Hydrochloride for Injection
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of abirritation success, abirritation success is defined as the percentage of time maintaining target abirritation in the entire drug administering time ≥ 70%. | within 3 days after administration of research drug |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time maintaining target abirritation in the entire drug administering time. | within 3 days after administration of research drug | — |
| Percentage of subjects receiving rescue analgesic drug | within 3 days after administration of research drug | — |
| The total dosage of rescue analgesic drug | within 3 days after administration of research drug | — |
| Receiving the total dosage of sedation | within 3 days after administration of research drug | — |
| Nursing Scores | within 3 days after discontinuation of research drug | The investigator will conduct an overall nursing assessment of the subject during the safety follow-up period, and the sum of each score will be calculated : (1) Overall Assessment of Adaptability to Sedation and the Intensive Care Environment, Very Easy=1, Easy =2, Fair =3, Difficult=4; (2) Overall Assessment of Adaptability to Endotracheal Intubation/Ventilation, Good=1, Fair =2,Poor=3; (3) Overall Assessment of Ease of Communication with the Patient, Very Easy=1, Easy =2, Fair =3, Difficult=4, Impossible=5; (4) Overall Assessment of Ease of Patient Care, Good=1, Fair =2,Poor=3. |
| Mechanical ventilation time. | From research drug administration to actual extubation , up to 72 hours | — |
| Extubation time | From discontinuation of research drug to actual extubation , up to 72 hours | — |
Countries
China
Outcome results
None listed