The Addition of Dexmedetomidine on Postoperative Sleep for Middle-aged and Elderly Patients With Gastric Cancer: A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 50
- 主要终点
- sleep time
研究概览
简要总结
The purpose of this study is to find out the effect of Dexmedetomidine for treatment of sleep deprivation, pain relief and postoperative recovery on middle-aged and elderly Patients with Gastric Cancer.
详细描述
Patients were randomized to receive sufentanil 0.05ug/kh/h + dexmedetomidine 0.1ug/kg/h (DEX group) or sufentanil 0.05ug/kg/h + saline (control group) for 48h. The primary outcome was the total sleep time during the first three days after surgery. The secondary outcomes included pain score, daily sufentanil consumption, time to functional recovery, length of hospital stay and side effects.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective gastric cancer operation Age ≧ 55 years ASA classification：I to III, BMI: 18-30 kg/m2 without the history of gastrointestinal surgery the normal coagulation function -
排除标准
- •the history of gastrointestinal surgery Gastrostomy and jejunostomy sleep apnea syndrome or severe osahs Severe liver and heart dysfunction Severe mental illness
研究组 & 干预措施
dexmedetomidine group
sufentanil + dexmedetomidine
干预措施: dexmedetomidine (Drug)
结局指标
主要结局
sleep time
时间窗: during the first three days after surgery
total sleep time during the first three days after surgery
次要结局
- daily sufentanil consumption(during the first three days after surgery)
- functional recovery(during the first three days after surgery)
- length of hospital stay(during the first three days after surgery)
- pain score(during the first three days after surgery)
- side effects(during the first three days after surgery)
研究者
Gao Tao
Attending
Nanjing PLA General Hospital