Analgesia for ICU patients
Conditions
Interventions
Part B (Group A):Treatment with intravenous injection or infusion of sufentanil citrate injection
PartA:Treatment with intravenous injection or infusion of sufentanil citrate injection
Part B (Group B):Treatment with intravenous injection or infusion of sufentanil citrate injection
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. (Part A, Part B) 18 years old<=age<=80 years old, gender is not limited; 2. (Part A, Part B) 18.0 kg/m2< = body mass index (BMI) < = 32.0 kg/m^2; 3. (Part A) ICU patients who are expected to require mechanical ventilation for more than 6 hours; 4. (Part A) Patient's required ICU sedation target RASS score within the range of -3<=RASS score <=+1; 5. (Part A) The use of any drug containing the active ingredient sufentanil is prohibited within 39 hours prior to the administration of the investigational drug; 6. (Part A, Part B) Patients or their guardians have a full understanding of the purpose and significance of this trial, voluntarily participate in this clinical trial, and sign the informed consent form; Patients or their guardians have a full understanding of the purpose and significance of this trial, voluntarily participate in this clinical trial, and sign an informed consent form; 7. (Part B) ICU patients with pre-dose mechanical ventilation time <=48h and are still expected to require mechanical ventilation for more than 12h; 8. (Part B) Patient required ICU sedation target RASS score within the range of -2<=RASS score <=+1;
Exclusion criteria
Exclusion criteria: 1. (Part A, Part B) Patients with known or suspected allergies or contraindications to various components of sufentanil citrate injection and propofol (including propofol injection, propofol medium/long chain fat emulsion injection and propofol emulsion injection) involved in the trial; 2. (Part A, Part B) Patients with predicted survival of 200mmHg and the oxygenation index is continuously decreasing; Circulatory system: within 4 hours prior to screening, an equivalent dose of norepinephrine (recommended based on vasoactive drug VIS index conversion) >0.4µg/kg/h is required to maintain MAP>=65mmHg; or an equivalent dose of norepinephrine (recommended based on vasoactive VIS index) =65mmHg; Severe renal impairment: chronic kidney disease [GFR<60ml/(min·1.73m2)], or acute renal failure up to KDIGO criteria grade 3; Severe hepatic impairment: chronic liver disease with a CTP score of =10, or acute liver failure; ?; 8. (Part A, Part B) Patients who have performed cardiopulmonary resuscitation within 1 month prior to enrollment, or patients who may need cardiopulmonary resuscitation during the trial; 9. (Part A, Part B) Those who may need surgery (except paracentesis or drainage), or tracheostomy, or renal replacement therapy (RRT), or plasmapheresis within 24 hours after enrollment; 10. (Part A, Part B) Patients requiring deep sedation (RASS=-4 or -5) or using neuromuscular blocking drugs within 24h of enrollment; ?; 11. (Part A, Part B) Patients with a history of substance abuse [including drug and non-drug (except smoking)] and drug abuse within 2 years prior to the administration of the investigational drug; 12. (Part A, Part B) Patients with positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb) or syphilis test or human immunodeficiency virus (HIV) antibody test; 13. (Part A, Part B) pregnant or lactating females, or patients with a positive blood/urine pregnancy test during the screening period, or those with planned fertility within 6 months after the end of administration of the investigational drug (including males); 14. (Part A, Part B) Patients who participated in any clinical trial of a drug or medical device as a subject within 1 month prior to the administration of the investigational drug (excluding in vitro diagnostic reagent clinical trial); 15. (Part A, Part B) Other circumstances judged by the investigator to be unsuitable for inclusion; 16. (Part A) Patients with hemoglobin < 80g/L during the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| During the administration of experimental drugs, the proportion of time that subjects were at the target level of analgesia and sedation (Part A: CPOT = 2 and -3 = RASS = 1); Part B: CPOT = 2 and -2 =;The percentage of time that subjects maintain the target analgesic level (CPOT = 2 points) during the administration of the investigational drug to the entire study administration time.;plasma concentration;The proportion of subjects who did not use salvage analgesia during the administration of the investigational drug and spent at least 70% of the time with a CPOT score of = 2.;Proportion of subjects who did not use salvage analgesia and were at the target level of analgesia and sedation at least 70% of the time during the administration of the investigational drug (Part A: CPOT<=2 and -3<=RASS<=1; Part B: CPOT<=2 and -2<=RASS<=1).;The incidence of AE/ADR in reducing blood pressure;The incidence of blood pressure lowering AE/ADR that requires intervention during the study period; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects who received additional propofol during the administration of the experimental drug.;The time from the end of administration of the experimental drug to the withdrawal of the subject;During the administration of experimental drugs, the dose of sedative propofol used (calculated separately for the combined dose of sedative propofol, the additional dose of propofol, and the total do;The time from the end of administration of the experimental drug to the subject's release from the ICU;The proportion of subjects who received the sedative propofol in combination during the administration of the experimental drug.; | — |
Countries
China
Contacts
Public ContactYou Shang
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed