Burn injury
Conditions
Interventions
Treatment Arm:The general anesthesia induction protocol was that propofol 4ug/ml TCI+remifentanil 1.5ng/ml TCI+esketamine 0.5mg/kg diluted to 10ml
The postoperative analgesia protocol was esketamine 0.5 mg/kg/d+ sufentanil 1µg/kg/d
Control Arm:The general anesthesia induction protocol was that propofol 4ug/ml TCI+remifentanil 1.5ng/ml TCI+10ml saline
The postoperative analgesia protocol was sufentanil 1µg/kg/d
Sponsors
The First Affiliated Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–65 years; 2. Patients diagnosed with severe/extra-severe burns in Department of Burn and Wound Repair, the First Affiliated Hospital of Sun Yat-sen University and Department of Burn of Guangzhou Red Cross Hospital; 3. General anesthesia with tracheal intubation and postoperative patient-controlled intravenous analgesia; 4. ASA score is grade I–grade III; 5.18 kg/m2<BMI<30kg/m2.
Exclusion criteria
Exclusion criteria: 1. Patients with intolerance or allergy to esmolol hydrochloride, ketamine, propofol, cisatracurium, opioids, and dexmedetomidine neostigmine; 2. Those who take benzodiazepine sleeping pills and opioid analgesics for a long time (continuously or intermittently); Patients taking hormones and psychotropic drugs for a long time before surgery; 3. Patients with severe cardiovascular disease history (such as myocardial ischemia, heart failure and arrhythmia); Angina pectoris (unstable angina pectoris) caused by insufficient blood supply to the coronary vessels of the heart, or myocardial infarction in the past 6 months; 4. Patients with hypertension whose blood pressure is not satisfactorily controlled by antihypertensive drugs (systolic blood pressure in sitting position in the screening stage =160 mmHg, and/or diastolic blood pressure in the screening stage = 100 mmHg); 5. Patients with craniocerebral injury, possible intracranial hypertension, cerebral aneurysms, cerebrovascular accidents and diseases of central nervous system; 6. Pre-operative liver function abnormality (Child C grade or TBIL = 1.5 × ULN); 7. Pre-operative renal dysfunction (BUN=1.5×ULN or Scr = 1.5 × ULN); 8. Patients with preoperative coagulation abnormalities (PT or PT-INR > 1.5× ULN, APTT >1.5×ULN), bleeding tendency (such as active peptic ulcer), or receiving thrombolytic or anticoagulant therapy; 9. Patients with a history of drug abuse and/or alcohol abuse within two years prior to admission, i.e., drinks more than 2 units of alcohol on average per day (1 unit =360 mL of beer or 45 mL of white wine with 40% alcohol content or 150 mL of wine); 10. Pregnant or lactating women; 11. Patients with a history of hyperthyroidism; 12. Patients with elevated intraocular pressure (such as glaucoma); 13. Patients with mental system diseases (schizophrenia, mania, bipolar disorder, mental disorder, etc.) and drug history and cognitive dysfunction patients; 14. Having participated in clinical drug trials as a subject in the past three months; 15. The researchers believe that patients should not participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| subjective analgesic efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| numerical rating scale, NRS;iFabp2 level;Apo-A2 level;CPP-Ab level;gastroin-testinal dysautonomia symptoms, GIDS;Length of postoperative analgesia;daily MME;MME;PCL-C score;PSQI score;SDS score;No. of PCA pump;Severity and No. of gastrointestinal adverse reactions during the study period;Times of hallucinations, irritability, and hypothermia during the study period after the first exhaust time; | — |
Countries
China
Contacts
Public ContactQiu-lan He
The First Affiliated Hospital, Sun Yat-Sen University
Outcome results
None listed