IMPACT OF SUGAMADEX ON AGITATION UPON EMERGENCE FOLLOWING ADULT NASAL SURGERIES.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 486
- 试验地点
- 1
- 主要终点
- the incidence of emergence agitation following adult nasal surgeries in patients receiving sugammadex versus a traditional neuromuscular blocking agent reversal method.
研究概览
简要总结
The impact of sugammadex on agitation upon emergence following adult nasal surgeries is an issue which needs to be studied that links anesthetic management with postoperative recovery.
详细描述
The included patients in the study will not be premedicated by sedatives, they will be preoxygenated for 5 minutes by 100% oxygen. The induction of anesthesia will be by fentanyl 100 microgram, 1.5 mg/kg lidocaine followed by propofol 2mg/kg, and rocuronium 0.5 mg/kg. oral intubation will be commenced and an oral pack will be inserted. Anesthesia will be maintained by sevoflurane 2% and N2O : O2 ratio of 50: 50.
Hypotensive anesthesia will be conducted by labetalol 10- 20 mg i.v. At the end of surgery inhalational anesthesia will be abandoned and muscle relaxant will be antagonized either by sugamadex 1mg/kg or neostigmine 0.05 mg/kg mixed with atropine 0.02 mg/kg. After awakening of the of the patients, emergence agitation will be assessed by Agitation and Emergence Score (AES): This scale is ranging from 0 (calm and cooperative) to 4 (combative, aggressive behavior).
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
- None
盲法说明
no need for masking
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients aging from 18 to 60 years old, undergoing nasal surgeries such as septoplasty, FESS or Rhinoplasty
- •ASA I and ASA II
排除标准
- •Patients receiving any medications which may affect recovery state e.g. Antipsychotics.
- •Obstructive sleep apnea patients
研究组 & 干预措施
Sugamadex group
Sugamadex group will receive sugamadex as a reversal agent of the muscle relaxant; rocuronium
干预措施: Sugamadex (Drug)
Neostigmine group
Neostigmine group will receive the neostigmine as a reversal of the muscle relaxant; rocuronium
干预措施: Neostigmine + Atropine (Drug)
结局指标
主要结局
the incidence of emergence agitation following adult nasal surgeries in patients receiving sugammadex versus a traditional neuromuscular blocking agent reversal method.
时间窗: perioperative
Agitation and Emergence Score (AES): This scale is ranging from 0 (calm and cooperative) to 4 (combative, aggressive behavior).
次要结局
- duration to full consciousness(Perioperative)
研究者
Sabah Nageeb
Lecturer of anesthesia and intensive care
Ain Shams University