Respiratory Benefits of Small Doses Muscle Relaxant in General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The time to extubation in minutes
研究概览
简要总结
This study will be held to assess the effect of minimal dose muscle relaxant on postoperative pulmonary function. The time to extubation in minutes will be the primary outcome as a clinical indicator of the return of muscle power. The extubation time will be defined as the time from injecting the muscle relaxant reversing agent given when regain the train of four (TOF) ratio to 0.9 till removal of endotracheal tube.
Intraoperative surgical conditions will be assessed in the form of surgeon satisfaction and the need for more muscle relaxant boluses. Postoperative complications as desaturation (peripheral oxygen saturation (Spo2) less than 90%), the need for re-intubation or ventilation support will be recorded. Patient lung will be assessed using ultrasound-based lung aeration score. Also, the diaphragmatic and intercostal muscle function will be assessed in the early postoperative period. Immediate postoperative pulmonary function tests will be evaluated using simple spirometer. Patients will be followed up for 28 days for detection of pulmonary complications.
详细描述
After arrival to the operating theater, a thoracic US examination will be done using LUS dynamic re-aeration score. Patients will be randomly allocated via sealed opaque envelopes into 2 groups of 30 patients each; control (C) group and minimal dose (Min) group.
For general anesthesia; intubating dose of muscle relaxant will be injected according to the study group; in C group; atracurium 0.5 mg/kg while in min group 0.2 mg/kg will be injected. The trial for intubation will be assessed and recorded. Train-of-four (TOF) stimulation will be maintained less than 2 throughout the intraoperative period in the control group. While, in the min group, boluses of muscle relaxant will be given only upon complain of the surgeon and after a bolus dose of propofol 0.5 mg/kg. When required, 20% of the initial dose of muscle relaxant will be provided as a bolus to achieve this goal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Basal US assessment and its repetition in the recovery room, will be done by an anesthetist who is not involved in randomization or anesthetic technique except, after ending the surgery and after dressing, he will be responsible for reversal agent injection and the extubation with recording the extubation time
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients
- •aged from 20 to 50 years old
- •scheduled for non-cardiothoracic surgery
- •under general anesthesia
- •in supine position
- •after informed consent
排除标准
- •American Society of Anesthesiologists (ASA) score more than 3
- •suspected full stomach or who will undergo intervention expected to necessitate profound muscle relaxation or dressing interferes with ultrasound (US) probe positioning
- •Lung parenchymatous disease
- •renal disease
- •hepatic disease
- •neuromuscular disease
- •electrolytes imbalanc
- •on medication interfere with muscle contraction
- •with known allergy to any drug used in the study
研究组 & 干预措施
control (C) group
Intubating dose of muscle relaxant will be atracurium 0.5 mg/kg
Maintenance doses of muscle relaxant will be given throughout the intraoperative period
to maintain the Train-of-four values continuously less than 2
干预措施: Atracurium Besylate regular dose (Drug)
minimal dose (M) group
Intubating dose of muscle relaxant will be 0.2 mg/kg will be injected
boluses of muscle relaxant will be given only upon complain of the surgeon and after a bolus dose of propofol 0.5 mg/kg. When required, 20% of the initial dose of muscle relaxant will be provided as a bolus to achieve this goal.
干预措施: Atracurium Besylate minial dose (Drug)
结局指标
主要结局
The time to extubation in minutes
时间窗: after injecting the muscle relaxant till removal of the tracheal tube
the time from injecting the muscle relaxant reversing agent given when regain the train of four (TOF) ratio to 0.9 till removal of endotracheal tube
次要结局
- Total doses of propofol used in M group post-induction(intraoperatively)
- lung aeration via Lung ultrasound dynamic re-aeration score(basal immmediate preoperative & with first 30 minutes postoperative)
- first Postoperative day complications(after removal of the tracheal tube and for 24 hours postoperative)
- Time to the first intraoperative need of muscle relaxant bolus (Atracurium), in the M group(Given intraoperatively only upon complain of the surgeon and after a bolus dose of propofol 0.5 mg/kg)
研究者
maha abou-zeid
Lecturer of anesthesia and surgical intensive care
Mansoura University