A Comparative Study Between Laryngeal Mask Airway and Magensium Sulphate in Attenuating Systemic Stress Response During Emergence of Patients Undergoing Supratentorial Tumours.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean arterial blood presure
研究概览
简要总结
To evaluate the efficacy of replacement of ETT with LMA and administration of Magnesium sulphate at the end of the surgery in attenuating systemic stress response during emergence of patients undergoing supratentorial tumours
详细描述
Rapid recovery from neuroanesthesia and early neurological examination are desirable in most cases.(1)Although, Systemic and cerebral hemodynamic changes caused by extubation and emergence from anesthesia may endanger neurosurgical patients and increase the risk of postoperative intracranial hemorrhage and cerebral edema and may even result in the requirement of reoperation.(2) During this phase, heart rate and arterial blood pressure increase leading to increases in cerebral blood flow and intracranial pressure.(3) Some studies have reported such hemodynamic effects in up to 50% of patients after supratentorial craniotomy.(4,5) Replacing the endotracheal tube (ETT) with laryngeal mask airway (LMA) prior to emergence from anesthesia is safe and effectively reduces the cardiovascular response.(6) The potential protective benefit of this approach has not yet been demonstrated for awakening neurosurgery patients, however.
Magnesium is the forth most abundant cation in the body and the second most abundant intracellular cation. It activates many of the enzyme systems.(7) Magnesium sulphate inhibits catecholamines release from adrenergic nerve terminals and from adrenal medulla, through blocking N-type of Ca-channel at peripheral sympathetic nerve ending so it is used to decrease the adverse cardiovascular effects during larygeoscopy and endotracheal intubation.(8) But its role in attenuating stress response during extubation is not well studied and need more research.
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)
盲法说明
The patients will be randomized into three equal groups. 60 slips of papers will be taken and labeled as group L (LMA), group M (Magnesium sulphate) and group C (Control). These slips will be placed in an envelope and one slip will be raised for each patient.
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
- •ASA physical status I, II.
- •Ages between 18 and 60 years.
- •Body mass index (BMI) <
- •Elective surgery
排除标准
- •Patients have cardiovascular, pulmonary, renal, hepatic and endocrine diseases.
- •Patients have any degree of disturbed conscious level.
- •Ages <18 or >60 years.
- •Patients have history of allergy to Magnesium sulphate.
- •Patients have uncontrolled hypertension during preoperative assessment.
- •Patients have risk of aspiration (eg. hiatus hernia)
- •Patients have difficult airway management during intubation with direct laryngoscope or time of intubation >30 seconds.
- •Failed ventilation with LMA.
- •Emergency surgery.
研究组 & 干预措施
Laryngeal mask airway group
20 slips of papers will be taken and labeled as group L (LMA) These slips will be placed in an envelope and one slip will be raised for each patient.
干预措施: Laryngeal mask airway (Device)
Laryngeal mask airway group
20 slips of papers will be taken and labeled as group L (LMA) These slips will be placed in an envelope and one slip will be raised for each patient.
干预措施: Magensium sulphate (Drug)
Laryngeal mask airway group
20 slips of papers will be taken and labeled as group L (LMA) These slips will be placed in an envelope and one slip will be raised for each patient.
干预措施: Control group (closure of anesthetics) (Other)
Magensium sulphate group
20 slips of papers will be taken and labeled as group M (Mgso4) These slips will be placed in an envelope and one slip will be raised for each patient
干预措施: Laryngeal mask airway (Device)
Magensium sulphate group
20 slips of papers will be taken and labeled as group M (Mgso4) These slips will be placed in an envelope and one slip will be raised for each patient
干预措施: Magensium sulphate (Drug)
Magensium sulphate group
20 slips of papers will be taken and labeled as group M (Mgso4) These slips will be placed in an envelope and one slip will be raised for each patient
干预措施: Control group (closure of anesthetics) (Other)
Control group (closure of anesthetics)
20 slips of papers will be taken and labeled as group C (Control) These slips will be placed in an envelope and one slip will be raised for each patient.
干预措施: Laryngeal mask airway (Device)
Control group (closure of anesthetics)
20 slips of papers will be taken and labeled as group C (Control) These slips will be placed in an envelope and one slip will be raised for each patient.
干预措施: Magensium sulphate (Drug)
Control group (closure of anesthetics)
20 slips of papers will be taken and labeled as group C (Control) These slips will be placed in an envelope and one slip will be raised for each patient.
干预措施: Control group (closure of anesthetics) (Other)
结局指标
主要结局
Mean arterial blood presure
时间窗: 5 minutes from closure of anesthetics until 15 minutes after extubation
Total dose of nitroglycerin needed in each group to maintain mean blood pressure within 20 % of basal line.
次要结局
- Intracranial pressure Measurement(1 and 10 minutes after extubation.)
- Quality of extubation(Time Onset of cough immediately after extubation)
- Level of consciousness(5 and 15 minutes after extubation)
- End of surgery and extubation(intraoperative)
研究者
Ahmed Abdalla
Assistant Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University
Cairo University