Abirritation in the ICU
Conditions
Interventions
Treatment group C: Remifentanil Hydrochloride for Injection:Remifentanil Hydrochloride for Injection
Treatment group B: Tegileridine Fumarate lnjection:Tegileridine Fumarate lnjection
Treatment group A: Tegileridine Fumarate lnjection:Tegileridine Fumarate lnjection
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion 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 =48h in the next; 3.Age >= 18 and 18 and < 30 kg/m^2; 5.Male and female fertile subjects must agree to use high-efficiency contraceptive measures with their partners from the signing of the informed consent to one month after the last administration of the test drug, and have no birth planning and no sperm/egg donation; The blood pregnancy test of fertile female subjects within 3 days before randomization must be negative and not in lactation.
Exclusion criteria
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 patients; 5. patients with bronchial asthma attack; 6. patients with acute intestinal obstruction; 7. patients with abdominal compartment syndrome; 8. multiple organ failure in screening period (SOFA score>9); 9. patients with malignant tumors who received radiotherapy, chemotherapy, targeted therapy and immunotherapy within the first month of randomization; 10. chronic pain requires long-term use of analgesics (the course of disease is more than 3 months); 11. severe liver dysfunction (child Pugh grade C); 12. severe renal dysfunction (definition of renal dysfunction: chronic renal insufficiency [glomerular filtration rate (GFR) = 65mmhg) 14. patients who need deep sedation (RASS=-4 or -5) or neuromuscular blocking drugs; 15. patients who may need surgery or tracheotomy during the administration of trial drug; 16. patients who had used monoamine oxidase inhibitors (MAOIs) in the previous two weeks were selected; 17. those who have a history of drug abuse, drug abuse, alcoholism and long-term use of psychotropic substances within 2 years before the screening period. Alcoholism is defined as regular drinking for more than 14 times/week (1 time=150ml wine or 360ml beer or 45ml spirit); 18. QTc in screening period: male>450ms, female>470ms (QTc is calculated by fridericia formula); Other ECG abnormalities that are clinically significant and may affect the safety assessment of the subjects as judged by the investigator; 19. human immunodeficiency virus antibody (HIV AB) was positive and serum Treponema pallidum antibody (TP AB) was positive at the time of screening (the titer of Treponema pallidum should be further checked, and if it was positive, it should be excluded); 20. drug abuse screening was positive in the screening period. 21. have participated in any other clinical study within the first 3 months of the randomization (the end time of the clinical study is the end time of the follow-up of adverse events, except for the subjects who do not use the investigational drugs or devices); 22. other circumstances in which the investigator judges that the subject is not suitable for participating in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of abirritation success; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose of propofol injection;Total dose of sufentanil;Proportion of sufentanil subjects;Nursing score;Duration of mechanical ventilation;Extubation time;Percentage of subjects' time in cpot<2 points during study administration;The percentage of the time when the subject was in cpots2 score and -2 score<rass <= 1 score in the study administration period;; | — |
Countries
China
Contacts
Public ContactYou Shang
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed