Peri-operative Dexmedetomidine Infusion in Mild Pre-eclamptic Patients Undergoing Elective Cesarean Section Under General Anesthesia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- postoperative analgesia
研究概览
简要总结
The purpose of this study is to investigate the effects of dexmedetomidine infusion on the stress response to intubation, postoperative analgesia, and renal functions (urinary output [UOP], creatinine and glomerular filtration rate [GFR]) in preeclamptic patient.
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)
盲法说明
double-blinding
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnant women
- •have mild preeclampsia ( Pre-eclamptic patients will be defined as having hypertension [systolic blood pressure (SBP) ≥140 mmHg and/or diastolic blood pressure (DBP)≥90 mmHg] accompanied by proteinuria first detected after 20 weeks of gestation).
- •Proteinuria is defined as at least 300 mg protein in 24 h urine collection [or ≥1+ dipstick (30 mg/dl) in a single urine sample] ).
- •American Society of Anesthesiologists (ASA) physical status of II or III.
- •age between 19 and 40 years
排除标准
- •patient refusal to consent (obsolete).
- •pre-existing neurological disease or psychic patients.
- •history of cardiac and respiratory system failure.
- •co-existing significant renal or liver disease.
研究组 & 干预措施
control group
Caesarian section will be performed under standard general anesthesia plus pre and intra operative saline infusion (placebo) in the same rate as dexmedetomedine starting 15 minutes before induction of general anesthesia and continue till peritoneum closure.
干预措施: placebo infusion (Drug)
Dex. group
Caesarian section will be performed under standard general anesthesia plus pre and intra operative Dexmedetomidine infusion in a dose of 0.5mic/kg/hour starting 15 minutes before induction of general anesthesia and continue till peritoneum closure.
干预措施: Dexmedetomidine infusion (Drug)
结局指标
主要结局
postoperative analgesia
时间窗: 24 hours postoperatively
through VAS score readings
次要结局
- untoward events(24 hours postoperatively)
- renal function(24 hours postoperatively)
- stress response(24 hours postoperatively)
研究者
Ahmad Mohammad Abd El-Rahman
lecturer
Assiut University