Dexmedetomidine Versus Magnesium Infusion in Reducing Agitations in Pediatric Patients Undergoing Adenotonsillectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The Cravero scale.
研究概览
简要总结
The aim of this study is evaluating the efficacy and safety of dexmedetomidine versus Magnesium for reducing emergence agitation after adenotonsillectomy in children.
Secondary outcome is to reduce child needs for analgesics and to reduce their dose.
详细描述
Preoperatively, Intravenous access using EMLA cream will be established in the ward. Child will be introduced to information about GA, OR and surgery. This information will include pictures of the staff and the OR, facemask, blood pressure cuff, etc. The child will move from ward to Pre-Anesthesia Care Unit accompanying his/her parents and anesthesia doctor to establish bonding. Cooperation on induction will be evaluated by using four-point scale with score of 1 to 2 being satisfactory and 3 to 4 being unsatisfactory. If the child develop agitation (Score 3 or 4) emergency Midazolam 0.1 mg/kg IV will be given and the child will be ruled out of study.
Monitors for non-invasive blood pressure, heart rate, electrocardiogram (ECG), pulse oximetry (SpO2) will be attached. Induction of anesthesia will be done using 8% Sevoflurane in oxygen gas with Atracurium 0.5 mg/kg and fentanyl 0.5 mcg/kg to facilitate tracheal intubation. The patients will be divided into three groups:
oGroup A (Dexmedetomidine Group): patients will receive Dexmedetomidine infusion (0.2 mcg/kg/hr) from the start of the surgery till the end of it.
oGroup B (Magnesium Group): patients will receive Magnesium infusion (10 mg/kg/hr) from the start of the surgery till the end of it.
oGroup C (Control Group): Patients will receive Normal Saline 0.9% infusion
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
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA I or II.
- •Age group: 4-12 years old.
- •The procedure expected to be completed within 1 hour.
排除标准
- •Patients with expected difficult airway management.
- •lack of consent.
- •known adverse effects to dexmedetomidine.
- •Mental retardation developmental delay, or neurological or psychiatric illness that may associate with agitation (cerebral palsy, seizure..etc.)
- •Hemodynamically unstable patients.
- •Persistent cough or high airway secretions.
- •Clinical signs of active infectious disease.
- •Coagulopathy (INR >1.5).
- •Obesity (BMI >30 Kg/m2 ).
- •Surgical complication
研究组 & 干预措施
Group A
patients will receive Dexmedetomidine infusion (0.2 mcg/kg/hr) from the start of the surgery till the end of it.
干预措施: Dexmedetomidine (Drug)
Group B
patients will receive Magnesium infusion (10 mg/kg/hr) from the start of the surgery till the end of it.
干预措施: Magnesium Sulphate (Drug)
Group C
Patients will receive Normal Saline 0.9% infusion
干预措施: Normal saline (Drug)
结局指标
主要结局
The Cravero scale.
时间窗: up to one hour in Post-anesthesia care unit
it has five steps from obtunded and unresponsive to wild thrashing behaviour requiring restraint. A score of ≥4 (from crying and difficult to console to wild thrashing) for a 5 or more min duration despite active calming efforts is regarded as indicative of ED. Behaviour Score Obtunded with no response to stimulation 1 Asleep but responsive to movement or stimulation 2 Awake and responsive 3 Crying (for \>3 min) 4 Thrashing behaviour that requires restraint 5
Ramsay sedation scores (RSS)
时间窗: up to one hour in Post-anesthesia care unit
1. Patient is anxious and agitated or restless, or both 2. Patient is co-operative, oriented, and tranquil 3. Patient responds to commands only 4. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus 5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus 6. Patient exhibits no response
次要结局
未报告次要终点
研究者
beshoy gamal
principal investigator
Ain Shams University