Combination of Magnesium Sulphate With Total Intravenous Anesthesia Optimized Surgical Field in Pediatric Cochlear Implant Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 主要终点
- Quality of surgical field
研究概览
简要总结
To determine the efficiency of addition of magnesium sulfate to total intravenous anesthesia (TIVA) in optimizing the surgical field during pediatric cochlear implant surgery. Also its effects on the intraoperative evoked stapedial reflex thresholds (ESRT) and the intraoperative anesthetic requirements were evaluated.
详细描述
Sixty-six ASA I and II children (1-6 years) undergoing cochlear implantation under general anesthesia were enrolled in this double blind, randomized study. Children were randomly allocated into two equal groups. Children in Group M (magnesium sulphate group) received an iv bolus dose of magnesium sulfate 40 mg Kg-1 over 5 minutes before induction of anesthesia followed by 15mg Kg-1 h-1 infusion until the start of skin closure. Children in Group C (Control group) received equivalent volumes of isotonic saline solution over the same period instead of magnesium sulphate. Haemodynamic variables, quality of surgical field, ESRT and the intraoperative anesthetic requirements were recorded
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA I and II children
排除标准
- •uncontrolled hypertension,
- •diabetes mellitus,
- •liver disease,
- •kidney disease,
- •heart disease,
- •allergy to magnesium sulphate,
研究组 & 干预措施
Magnesium sulphate
Group M
干预措施: Magnesium sulphate (Drug)
Na CL 0.9%
group C
干预措施: Na CL 0.9% (Other)
结局指标
主要结局
Quality of surgical field
时间窗: at the end of the surgey
using Fromme's-Boezaart scale (0 to 5). A score of ≤ 2 was considered to be optimal
次要结局
- The operative time(Intraoperative)
- ESRT responses(After insertion of the electrode and after reversal of any residual muscle relaxant (TOF response > 0.9),)
- Heart rate(baseline, after surgical incision, Hypotensive period, after LMA removal and at recovery room admission.)
- The anesthesia time.(Intraoperative)
- Mean arterial blood pressure(Intraoperative)
- Anesthetic consumption(Intraoperative)
研究者
Wahba bakhet
Lectrure of anesthesia
Ain Shams University