The Effect of Esketamine on the Quality of Recovery After Modified Radical Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Quality of recovery scores (QoR-15)
研究概览
简要总结
Some studies have reported that intravenous esketamine reduce postoperative pain intensity. The investigators investigated whether esketamine could improve the the quality of recovery after modified radical mastectomy.
详细描述
A total of 111 patients were randomly allocated into 3 groups. Patients in group LE received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 2 µg/kg/min until before suture the skin. Patients in group HE received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 4 µg/kg/min until before suture the skin. Patients in group CON received a bolus infusion of the same volume saline before cutting the skin, and then the same volume saline was infused until before suture the skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists (ASA) physical status
- •Scheduled for elective modified radical mastectomy
排除标准
- •Severe respiratory disease
- •Renal or hepatic insufficiency
- •History of preoperative psychiatric
- •Preoperative hypertension
- •Preoperative history of chronic pain
研究组 & 干预措施
Low-dose esketamine infusion on the quality of recovery after radical mastectomy
Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 2 µg/kg/min until before suture the skin.
干预措施: Low-dose esketamine infusion (Drug)
Low-dose esketamine infusion on the quality of recovery after radical mastectomy
Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 2 µg/kg/min until before suture the skin.
干预措施: High-dose esketamine infusion (Drug)
Low-dose esketamine infusion on the quality of recovery after radical mastectomy
Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 2 µg/kg/min until before suture the skin.
干预措施: Saline infusion (Drug)
High-dose esketamine infusion on the quality of recovery after radical mastectomy
Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 4 µg/kg/min until before suture the skin.
干预措施: Low-dose esketamine infusion (Drug)
High-dose esketamine infusion on the quality of recovery after radical mastectomy
Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 4 µg/kg/min until before suture the skin.
干预措施: High-dose esketamine infusion (Drug)
High-dose esketamine infusion on the quality of recovery after radical mastectomy
Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 4 µg/kg/min until before suture the skin.
干预措施: Saline infusion (Drug)
Saline infusion on the quality of recovery after radical mastectomy
Patients received a bolus infusion of the same volume saline before cutting the skin, and then the same volume saline was infused until before suture the skin.
干预措施: Low-dose esketamine infusion (Drug)
Saline infusion on the quality of recovery after radical mastectomy
Patients received a bolus infusion of the same volume saline before cutting the skin, and then the same volume saline was infused until before suture the skin.
干预措施: High-dose esketamine infusion (Drug)
Saline infusion on the quality of recovery after radical mastectomy
Patients received a bolus infusion of the same volume saline before cutting the skin, and then the same volume saline was infused until before suture the skin.
干预措施: Saline infusion (Drug)
结局指标
主要结局
Quality of recovery scores (QoR-15)
时间窗: 1 day after operation
Our primary outcome was quality of recovery scores (QoR-15) 1 day after operation
次要结局
- Pain visual analogue scale scores(The first 48 hours after operation)