Evaluation of the Effect of Appropriate Sedation for Patients After Gastrectomy: A Prospective Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- white blood cell count (10^9/L)
研究概览
简要总结
To evaluate the efficacy and safety of appropriate postoperative sedation with dexmedetomidine for patients after gastrectomy. Prospective randomised controlled study was conducted from October 2015 and December 2015 among patients after gastrectomy. The investigators are going to enroll patients who received abdominal surgeries. One group receive sedative along with analgesic and the other group analgesic only for the other group on the first 24 hours after surgeries and follow up for 3 days.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-85 years old
- •underwent gastrectomy in the hospital and operation duration lasted at least 2 hours
排除标准
- •take part in other clinical trials
- •quinolone antibiotics intake 4 weeks prior to or within the study
- •NSAIDS intake within one month
- •history of peptic ulcer
- •respiratory insufficiency
- •renal insufficiency
- •acute hepatitis or severe liver disease (Child-Pugh class C)
- •pregnancy or lactation
- •abnormal ECG with clinical significance
- •uncontrolled hypotension
- •bleeding tendency or hematological diseases
- •untreated mechanical intestinal obstruction
- •unable to express or any kind of mental disease.
研究组 & 干预措施
Tramadol and flurbiprofen
Only routine analgesic(tramadol and flurbiprofen) are applied to this group of patients.
干预措施: tramadol and flurbiprofen (Drug)
Dexmedetomidine,tramadol and flurbiprofen
Both sedative and analgesic(dexmedetomidine, tramadol and flurbiprofen) are applied to this group of patients.
干预措施: dexmedetomidine, tramadol and flurbiprofen (Drug)
结局指标
主要结局
white blood cell count (10^9/L)
时间窗: 1-3d after gastrectomy
evaluate postoperative inflammatory response, blood sample collected at 6:00am for 1-3d after gastrectomy
postoperative pain assessed by Prince Henry Pain Scale
时间窗: 1-3d after gastrectomy
assessed by Prince Henry Pain Scale by investigators at 8:00 am after surgeries until discharge from ICU
recovery of gastrointestinal function assessed by time to first defecation after surgery
时间窗: 30 days after gastrectomy
assessed by time to first defecation after surgery
C-reactive protein (mg/L)
时间窗: 1-3d after gastrectomy
evaluate postoperative inflammatory response, blood sample collected at 6:00am for 1-3d after gastrectomy
次要结局
- percentage of time within target sedation range(1-3d after gastrectomy)
- risk of bradycardia requiring interventions(1-3d after gastrectomy)
- risk of hypotension requiring interventions(1-3d after gastrectomy)
- use of opioids and use of benzodiazepins(1-3d after gastrectomy)
研究者
Juanhong Shen
Director, PhD, Principal Investigator, Resident Physician
Chinese Medical Association