Comparison Between Dexmedetomidine and Midazolam Nebulization as Procedural Sedation During Cesarean Delivery Under Spinal Anesthesia in Pre-eclamptic Parturients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Chane in the level of sedation
研究概览
简要总结
Null hypothesis: There is no difference between the effects of nebulization of dexmedetomidine and midazolam as procedural sedation during cesarean delivery under spinal Anesthesia in pre-eclamptic parturients Alternative hypothesis: There is difference between the effects of nebulization of dexmedetomidine and midazolam as procedural sedation during cesarean delivery under spinal anesthesia in pre-eclamptic parturients
详细描述
Site of study:
This study will be carried out in operating theater of obstetrics at Zagazig University Hospitals.
Withdrawal Criteria: The woman has the right to withdraw from the study at any time without any negative consequence on their medical or surgical treatment plan.
Double -blind randomized clinical trial. All patients will be hospitalized and visited a day before the surgery, full history with physical examination and routine investigation will be done, the nature and complications of the study will be explained in detail to the patient and informed written consent will be obtained from every woman.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 21-38 years old.
- •Mild and moderate preeclampsia parturient.
- •American Society of AnesthesiologistPhysical status II.
- •Body Mass Index (BMI) (25-35kg/m²).
- •Type of operations: elective cesarean section under spinal anesthesia.
- •Written informed consent from the parturient.
排除标准
- •Altered mental state.
- •Women with known history of allergy to study drugs.
- •Women with uncontrolled diabetes mellitus, bleeding, coagulation disorders, advanced hepatic, renal, cardiovascular, respiratory disease and neuropsychiatric disorders.
- •Patients receiving anticonvulsants or antidepressants.
- •Sever preeclampsia, intrauterine growth restriction or fetal compromise.
研究组 & 干预措施
nebulized dexmedetomidine
parturient will receive nebulized 3ug/kg dexmedetomidine diluted in normal saline (0.9%) solution till total volume of nebulized solution will become 5 ml and will be nebulized by a standard hospital jet nebulizer via mouthpiece, with a continuous flow of 100% oxygen at 6 L/min. for 15 minutes, and the treatment will be stopped when the nebulizer will be began to sputter.
干预措施: Nebulized dexmedetomidine (Drug)
nebulized midazolam
parturient will receive nebulized 0.2 mg/kg midazolam diluted in normal saline (0.9%) solution till total volume of nebulized solution will become 5 ml and will be nebulized by a standard hospital jet nebulizer via mouthpiece, with a continuous flow of 100% oxygen at 6 L/min. for 15 minutes, and the treatment will be stopped when the nebulizer will be began to sputter.
干预措施: Nebulized midazolam (Drug)
结局指标
主要结局
Chane in the level of sedation
时间窗: at 0 minute (immediately after nebulization) , 5 minutes then every 15 minutes intraoperative
Change in the level of sedation will be assessed using Ramasy Sedation Assessment Scale Ramsay Sedation Scale 1= Patient is anxious and agitated or restless, or both 3= Patient responds to commands only 4= Patient exhibits brisk response to light glabellar tap or loud auditory stimulus 5= Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus 6= Patient exhibits no response
次要结局
- Heart rate(Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative.)
- The discharge time from Post Anesthesia Care Unite (PACU) .(up to 30 minutes postoperative)
- Maternal satisfaction with procedure(up to 24hour postoperative)
- APGAR score(at 1 and 5 min after delivery)
- Mean arterial blood pressure(Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative.)
- Oxygen saturation(Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative.)
研究者
Alshaimaa Abdel Fattah Kamel
principle investigator
Zagazig University