A Comparison of the Sedative Effect of Ketamine and Midazolam During Spinal Anaesthesia for Elective Unilateral Inguinal Hernia Repair: A Randomized Comparative Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Time for the onset of sedation in minutes assessed by modified observer's assessment of alertness/sedation score
研究概览
简要总结
Patients during spinal anesthesia should be sedated.
详细描述
Spinal anesthesia offers a number of advantages to both the patient and the physician. However, patients are often reluctant to remain awake during a procedure. Sedation has been shown to increase patient satisfaction during regional anesthesia and may be considered as a means to increase the patient's acceptance.Therefore, provision of adequate sedation is important if the advantages of spinal anesthesia are to be fully appreciated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged from 18 to 50 years old undergoing elective unilateral inguinal hernia repair with no neurological, cardiovascular and hepato-renal abnormalities.
排除标准
- •Age: younger than 18 or older than
- •Psychatric or neurological disorders.
- •Cardiovascular disorders.
- •Coagulation disorders.
- •Contraindications to neuraxial block (allergy to L.A, peripheral neuropathy, prior spine surgery).
研究组 & 干预措施
Ketamine
Patients will receive IV ketamine 0.5 mg/kg diluted in normal saline to a volume of 50 ml over 10 min
干预措施: Ketamine (Drug)
Midazolam
Patients will receive IV midazolam 0.03 mg/kg diluted in normal saline to a volume of 50 ml over 10 min
干预措施: Midazolam (Drug)
结局指标
主要结局
Time for the onset of sedation in minutes assessed by modified observer's assessment of alertness/sedation score
时间窗: 90 minutes after spinal anesthesia
assessed by modified observer's assessment of alertness/sedation score
次要结局
未报告次要终点
研究者
Seham Mohamed Moeen Ibrahim
Principal Investigator
Assiut University