Efficacy of Dexmedetomidine Infusion Without Loading Dose on Hemodynamic Variables and Recovery Time During Craniotomy: A Randomized Double Blinded Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mean areterial blood pressure
研究概览
简要总结
There is no clear consensus among neuroanesthesiologists regarding which anesthetic regimen is optimal for craniotomy. Propofol and short-acting opioids (such as remifentanil, fentanyl, or sufentanil) are commonly used. However, use of opioids is associated with increased risk of respiratory depression and postoperative nausea and vomiting. Dexmedetomidine is a highly selective α2-adrenoreceptor agonist that has been considered as a useful and safe adjunct to anesthesia for various surgical procedures
详细描述
The investigators designed this randomized, double-blind study to evaluate the effectiveness of administration of Dexmedetomidine infusion at a dose of 0.5 µg/kg/h without loading dose during elective supratentorial craniotomy under GA. The investigators will compare intraoperative hemodynamics in both groups, intraoperative analgesic consumption, intraoperative blood loss, postoperative sedation scores, intraoperative need for rescue hypotensive agents, and finally the satisfaction of surgeons.
To our knowledge, the present study is the first to evaluate the effect of Dexmedetomidine infusion without loading dose in elective supratentorial craniotomy
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American society of anesthesiologists- Physical status (ASA-PS) I and II patients,
- •aged 18 to 65 years
- •both sexes
- •undergoing elective supratentorial craniotomy for tumor resection
排除标准
- •Patients under 18 years of age
- •pregnancy,
- •emergency surgery
- •patients with a Glasgow Coma Score (GCS) less than
- •Those who had respiratory or cardiac dysfunction, renal insufficiency, liver impairment, or bleeding disorders
研究组 & 干预措施
Group D
Group D: Patients received 0.5 µg/kg/h of Dexmedetomidine. Dexmedetomidine dosage was diluted in 50 ml syringe of normal saline
干预措施: Dexmedetomidine (Drug)
Group C
Patients received equal volume and rate of normal saline as Group D.
干预措施: normal saline (Drug)
结局指标
主要结局
Mean areterial blood pressure
时间窗: 4 to 8 hours
incidence of intraoperative hemodynamic stability
Heart rate
时间窗: 4 to 8 hours
incidence of intraoperative hemodynamic stability
Number of Participants needed rescue agents
时间窗: 4 to 8 hours
次要结局
- Recovery time in minutes(At the end of operation)
- Postoperative sedation level(1st 2 hours postoperatively)
研究者
Raham Hasan Mostafa, MD
Assistant Professor of Anesthesia
Ain Shams University