A comparative study of two different doses of magnesium sulphate pre-treatment on the onset and duration of rocuronium induced neuromuscular blockade, A randomised controlled double blinded study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To compare two different doses of magnesium sulphate pre-treatment on the onset of rocuronium induced neuromuscular blockade
研究概览
简要总结
Rapid sequence induction usually applies when tracheal intubation must be performed in a patient who is suspected of having a full stomach and who is at risk of pulmonary aspiration of gastric contents. The goal is to secure the airway without producing any regurgitation or vomiting. The second objective involves minimization of induction–intubation interval, which means that a short-acting hypnotic agent should be administered with a rapidly acting neuromuscular-blocking agent.
Rocuronium, a nondepolarizing muscle relaxant, has been shown to provide adequate intubating conditions with rapid onset, an intermediate duration and no obvious side effects. Rocuronium produces faster neuromuscular blockade compared with other nondepolarizing neuromuscular-blocking drugs.
Magnesium potentiates neuromuscular blockade through the inhibition of calcium-mediated release of acetylcholine from the presynaptic nerve terminals at the neuromuscular junction and also a decrease in postsynaptic sensitivity to acetylcholine and direct effects on the membrane potential of myocytes, thus augmenting the effect of nondepolarizing neuromuscular blockers.
After pre-treatment with magnesium sulphate (MgSO4), an increased speed of onset and a prolongation of the recovery period of neuromuscular blockade have been observed with atracurium and vecuronium.
It may be assumed that the effect of the magnesium ion on the neuromuscular endplate is both concentration and time dependent.
Magnesium infusion, rather than a bolus injection immediately before the injection of the NMBA, has an impact on neuromuscular blockade. In theory, MgSO4 pre-treatment should reduce the onset time of a rocuronium-induced block to an extent that makes it an interesting alternative to succinylcholine for rapid sequence induction.
After institutional human ethical commitee approval and CTRI registration. patients with in the inclusion criteria are selected.
Totally 90 patients will be participating in this study under three groups with each group containing 30 patients.
GROUP 1: n=30
Infusion of 50 mg/kg of magnesium sulphate will be given over 10 min prior to induction with 0.6 mg/kg of rocuronium.
GROUP 2: n=30
Infusion of 60 mg/kg of magnesium sulphate will be given over 10 min prior to induction with 0.6 mg/kg of rocuronium.
GROUP 3: n=30
Infusion of 100ml normal saline will be given over 10 min prior to induction with 0.6 mg/kg of rocuronium, will be considered as the control group.
and the onset and duration of rocuronium induced neuromuscular blockade is noted with TOF monitor and results are noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA Grade I and Grade II patients Mallampatti Grade I and Grade II.
排除标准
- •Refusal of consent Known or anticipated difficult airway.
- •Emergency surgeries.
- •Pregnant patients.
- •Patients with a BMI of 35 or more Patients with significant hepatic, renal, metabolic, neuro-muscular disorder Those with allergy to Rocuronium.
结局指标
主要结局
To compare two different doses of magnesium sulphate pre-treatment on the onset of rocuronium induced neuromuscular blockade
时间窗: It is assessed every 30 sec with TOF monitoring. | Onset is noted when TOF becomes zero.
次要结局
- To compare two different doses of magnesium sulphate pre-treatment on the duration of rocuronium induced neuromuscular blockade and haemodynamic changes.(It is monitored every 2 minutes .Duration of action is determined when TOF zero becomes TOF 1)