Phase 4 Study of Effects of Dexmedetomidine on Prevention of Side Effects of Hemabate in Cesarean Section Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 主要终点
- vomiting
研究概览
简要总结
Hemabate is often used for gynecological patients. Hemabate is associated with many side effects, including a burning sensation in the stomach, nausea, vomiting, diarrhea etc. It is reported that dexmedetomidine reduce gastrointestinal reaction during perioperative period. We design this clinical trial to find if dexmedetomidine can prevent the side effects of hemabate in Cesarean Section patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •gynecological patients
排除标准
- •Neuromuscular and endocrine diseases
- •Allergic reactions to a2-adrenergic agonist
- •Previous abdominal surgery including prior caesarean section.
研究组 & 干预措施
placebo group
received 20 ml intravenous physiological saline
干预措施: placebo (Drug)
low dose dexmedetomidine group
received 0.5μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline
干预措施: low dose dexmedetomidine (Drug)
hemabate+high dose dexmedetomidine group
received 1μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline
干预措施: high dose dexmedetomidine (Drug)
结局指标
主要结局
vomiting
时间窗: 24h postoperatively
elevated blood pressure
时间窗: 24h postoperatively
fever
时间窗: 24h postoperatively
SpO2 Change
时间窗: participants will be followed for the duration of surgery, an expected average of 2 hours
nausea
时间窗: 24 h postoperatively
diarrhea
时间窗: 24h postoperatively
headache
时间窗: 24h postoperatively
systolic blood pressure and diastolic blood pressure change
时间窗: participants will be followed for the duration of surgery, an expected average of 2 hours
Heart rate change
时间窗: participants will be followed for the duration of surgery, an expected average of 2 hours
chest congestion
时间窗: 24h postoperatively
次要结局
未报告次要终点
研究者
Jin Ni
Department of Anesthesiology
Guangzhou Women and Children's Medical Center