Intraoperative Small-dose Esketamine Infusion for Pain Control in Burn Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Intraoperative sufentanil
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All intubated adult burn patients( age>18 ), presenting to the operating room;
- •Burn area> 30%.
排除标准
- •Allergy to Esketamine or benzodiazepines
- •Esketamine or ketamine use in the preceding 24 hours
- •Increased intracranial pressure
- •Increased intraocular pressure
- •Porphyria
- •Thyroid disorders
- •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.
研究组 & 干预措施
Esketamine
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
干预措施: Esketamine (Drug)
Saline
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
干预措施: Saline (Drug)
结局指标
主要结局
Intraoperative sufentanil
时间窗: 24 hours
For all participants, the dose of intraoperative sufentanil will be recorded in micrograms and compared between the two arms.
次要结局
- Intraoperative cardiac index(24 hours)
- Intraoperative heart rate(24 hours)
- Intraoperative blood pressure(24 hours)
- Post-operative recovery time(24 hours)