Critical illness
Conditions
Interventions
Standard care group: A minimal dose of sufentanil is used as the sole analgesic for pain management
Esketamine group:Esketamine hydrochloride was infused at a rate of 0.2 mg/kg/h in addition to the minimal dose of sufentanil for pain management
Sponsors
Department of Critical Care Medicine, Chongqing University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18-70 years; 2. Non-surgical patients; 3. Patients were intubated and mechanically ventilated within 12 hours and expected to require ventilation for longer than 48 hours.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breast-feeding; 2. Medical condition prevented assessment of RASS and CPOT; 3. Contraindications to esketamine hydrochloride; 4. Contraindications to sufentanil, propofol, midazolam, or their excipients; 5. Require deep sedation (RASS<=-4) or continuous infusion of neuromuscular blocker or both; 6. Suspected or proven acute primary brain injury (traumatic brain injury, cerebral infarction, intracranial haemorrhage, spinal cord injury, hypoxic-ischaemic encephalopathy, hydrocephalus, or cerebral oedema); 7. Ejection Fraction <30%, cardiogenic shock, and acute myocardial infarction; 8. Endogenous creatinine clearance rate <30 mL/min; 9. End-stage liver disease (Child-Pugh grade C); 10. Require surgery or tracheotomy within 48 hours; 11. Ketamine or esketamine hydrochloride is required due to status epilepticus or other diseases; 12. History of drug or alcohol abuse or both; 13. Palliative care or expected to die within 48 h; 14. History of dementia or mental illness, or require psychotropic medication; 15. Refusal to sign the informed consent form; 16. Participating in clinical trials of other drugs, or having participated in other clinical trials within 30 days; 17. As determined by the clinician, does not require opioids for analgesia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean hourly sufentanil consumption during the treatment period; | — |
Secondary
| Measure | Time frame |
|---|---|
| The mean hourly consumption of sedatives during the treatment period;The proportion of requiring frequent suctioning(/2-hour translation <= 1 time/2 hours <= 1 time/2 hours) during the treatment period;The proportion of uncontrolled agitation (Removal of artificial airway and tubing or aggressive behavior) during the treatment period;Mechanical Ventilation-free days;The incidence of ICU delirium, the number of delirium days, and the proportion of psychotropic drugs used for delirium;Adverse events (AE), severe adverse events (SAE), and adverse events that may be related to the study drug;Length of ICU stay;AGI score, enteral nutrition tolerance score, gastric residual volume, and intra-abdominal pressure in the first 7 days after randomisation (in the ICU);Liver function, renal function, and myocardial enzyme in the first 3 days and the 7th day after randomisation (in ICU);Nutrition compliance rate on the 4th and 7th day after randomisation (in ICU);The CPOT and RASS assessment during the treatment period;The mean hourly consumption of sufentanil on the 5th day after randomisation;The SOFA score in the first 7 days after randomisation (in ICU);The APACHE-II score of the 7th day after randomisation (in ICU);Vasopressor-free day;Length of hospital stay;28-day mortality after randomisation; | — |
Countries
China
Contacts
Public ContactLong Yi
Chongqing University Cancer Hospital
Outcome results
None listed