Intraoperative Small-dose Esketamine Infusion for Pain Control in Burn Patients

Study Overview
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Brief Summary
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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.

Official Title
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Intraoperative Small-dose Esketamine Infusion for Pain Control in Burn Patients

Conditions
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Burns

Intervention / Treatment
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* Drug: Esketamine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esketamine<br>Participants randomized to this arm will receive Esketamine (1 mg/ml) infused at 0.1 mg/kg/hour (0.1 ml/kg/h) throughout the operation | Drug: Esketamine<br>* 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) .<br>|
| Placebo Comparator: Saline<br>Participants randomized to this arm will receive 0.9 mg/ml sodium chloride, infused at a rate of 0.1 ml/kg/hour throughout the operation | Drug: Saline<br>* 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.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative sufentanil | For all participants, the dose of intraoperative sufentanil will be recorded in micrograms and compared between the two arms. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative blood pressure | For all participants, blood pressure will be recorded and compared between the two arms. | 24 hours | 
| Intraoperative heart rate | For all participants, heart rate will be recorded and compared between the two arms. | 24 hours | 
| Intraoperative cardiac index | For all participants, cardiac index will be recorded and compared between the two arms. | 24 hours | 
| Post-operative recovery time | For all participants, the recovery time of spontaneous breathing will be recorded. | 24 hours |