Evaluation of Effectiveness of Two Different Doses of Mivacurium in Modified Rapid Sequence Intubation for Emergency Surgery ,Prospective Randomized Double Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Intubation conditions during RSI.
研究概览
简要总结
Mivacurium can be considered as an optimal choice for muscle relaxation in short duration surgeries, as butyrylcholinesterase can rapidly and reliably degrade this benzylisoquinoline muscle relaxant in vivo. However the histamine release related to a rapid high-dose injection, unsatisfactory intubation conditions and unexpected delay in recovery in patients may be encountered with butyrylcholinesterase deficiency
详细描述
Intubation in emergency and full stomach patients stands as a challenge in anaesthesia. Rapid sequence induction (RSI) is the key player technique in avoiding gastric contents aspiration risk. Non-depolarizing neuromuscular blocking agents as mivacurium are of clinical significance in the anesthetic management of patient. Mivacurium has been has been preferred in situations who necessitating hemodynamic solidity all over the surgery, as only transient tachycardia and hypotension were recorded
Aim of work Using high doses of mivacurium can provide accepted condition of emergency intubation within favorable time - monitoring hemodynamics changes during and after intubation, time of recovery from high doses of muscle relaxant
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blind
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20-60 year old patients.
- •American society of anaesthesia (ASA) 1 and
- •Emergency surgery.
排除标准
- •neuromuscular disease.
- •Suspected desaturation.
- •Severe cardiac disease.
- •Severe pulmonary disease.
研究组 & 干预措施
Miva 3
"Mivacurium chloride" ("Mivacron®") 0.3 mg/kg 3 times effective dose (ED) 95 iv during induction recording intubation condition during rapid sequence intubation within 90 sc monitoring hemodynamic changes during intubation ,time to recover to T1
干预措施: "Mivacurium Chloride" (Drug)
Miva 4
"Mivacurium chloride" ("Mivacron®") 0.4 mg/kg 4 times effective dose (ED) 95 iv during induction
recording intubation condition during rapid sequence intubation within 90 sc monitoring hemodynamic changes during intubation,time to recover to T1
干预措施: "Mivacurium Chloride" (Drug)
结局指标
主要结局
Intubation conditions during RSI.
时间窗: 3 months
Jaw relaxation or ease blade insertion was graded as easy (3), moderate (2), difficult (1) and impossible (0). Vocal cord positions were ranked as abducted (3), moving (2), closing (1) and closed (0). Response to intubation was graded as no movement (3), slight diaphragmatic movement (2), mild coughing (1) and severe coughing or bucking (0). The total scores of the three variables were rated as excellent (8-9), good (6-7), fair (3-5) and poor (0-2). Good and excellent intubating conditions were considered 'clinically acceptable'.
次要结局
- time/minute to T1 recovery monitoring(12 weeks)
- change in heart rate beat/minute:(12 weeks)
- change in mean arterial bood pressure (MAP) mmHg/minute:(12 weeks)
研究者
Ismail Mohamed Abdelgawad Ahmed
DOCTOR
Al-Azhar University