Burns
Conditions
Brief summary
This study aim to determine whether a small-dose esketamine infusion can be used for pain control in severe burn patients, and thereby reduce the total intra-operative opioid requirement. Secondary objectives are to determine whether this low-dose esketamine infusion will increase the stability of circulation.
Interventions
DRUGEsketamine
Esketamine is infused through the whole period of surgery. Participants randomized to the esketamine arm will receive 1 mg/ml solution infused at 0.1 mg/kg/hour (0.1 ml/kg/h) .
DRUGSaline
Participants randomized to the placebo arm will receive 0.9 mg/ml sodium chloride, infused at a rate of 0.1 ml/kg/hour throughout the surgery.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All intubated adult burn patients( age\>18 ), presenting to the operating room; * Burn area\> 30%.
Exclusion criteria
* Allergy to Esketamine or benzodiazepines * Esketamine or ketamine use in the preceding 24 hours * Increased intracranial pressure * Increased intraocular pressure * Porphyria * Thyroid disorders * Seizures * Acute myocardial ischemia * Children (patients under age 18), prisoners, pregnant or breastfeeding women, patients with psychosis, patients with developmental delay, and any condition which, in the opinion of the investigator, would prevent full participation in this study or would interfere with the evaluation of the trial endpoints.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative sufentanil | 24 hours | For all participants, the dose of intraoperative sufentanil will be recorded in micrograms and compared between the two arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative blood pressure | 24 hours | For all participants, blood pressure will be recorded and compared between the two arms. |
| Intraoperative heart rate | 24 hours | For all participants, heart rate will be recorded and compared between the two arms. |
| Intraoperative cardiac index | 24 hours | For all participants, cardiac index will be recorded and compared between the two arms. |
| Post-operative recovery time | 24 hours | For all participants, the recovery time of spontaneous breathing will be recorded. |
Countries
China
Contacts
Primary ContactQingyu SHI, MD
Outcome results
None listed