Effectiveness of Intravenous Ketodex Versus Ketofol for Obtunding Hemodynamic Responses to Laryngoscopy and Tracheal Intubation in Adult Elective Middle Ear Surgery Patients: A Prospective Randomized Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Heart rate accompanying laryngoscopy and tracheal intubation with cuff inflation
研究概览
简要总结
Laryngoscopy and tracheal intubation lead to tachycardia and hypertension due to increase in the plasma catecholamines subsequent to sympathetic stimulation.
详细描述
Various prophylactic interventions have been tried to blunt the hemodynamic stress response to laryngoscopy and tracheal intubation. The ketamine-dexmedetomidine combination (ketodex) and ketamine-propofol combination (ketofol) may be of benefit in maintaining hemodynamic stability and reducing potential side effects of each drug.
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)
盲法说明
Double (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients scheduled for elective middle ear surgery under general anesthesia, ASA status I-II, aged from 18 to 60 years old of either sex.
排除标准
- •Full stomach or emergency surgery
- •Any known contraindications or allergy to ketamine, dexmedetomidine, or propofol
- •Pregnancy or breastfeeding women
- •Body mass index (BMI) > 35 Kg/m2
- •History of hepatic, renal, or cardiac disease
- •Patients in whom the duration of laryngoscopy will last more than 25 seconds
- •Chronic opioid use, or history of neuropsychiatric disorders
- •Patient refusal
结局指标
主要结局
Heart rate accompanying laryngoscopy and tracheal intubation with cuff inflation
时间窗: The fifth minute after laryngoscopy and tracheal intubation with cuff inflation
Assessed in beats per minute
次要结局
未报告次要终点
研究者
Seham Mohamed Moeen Ibrahim
Assiut University
Assiut University