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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esketamine | Experimental | 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 |
|
| Saline | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esketamine | Drug | 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) . |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingyu SHI, MD | Contact | +8613777564585 | shiqinyu_001@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Min YAN, MD | 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd affiliated hospital, School of Medicine, Zhejiang Universtiy, China | Recruiting | Hangzhou | Zhejiang | 310003 | China |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline | Drug | 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. |
|
|
| 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 |
| D017670 |
| Sodium Compounds |