Effect of Magnesium Sulphate Pretreatment on the Onset and Duration of Intense and Deep Neuromuscular Block of Rocuronium Versus Cis-Atracurium in Pediatric Abdominal Surgery
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- The time of no response to nerve stimulation (seconds)
研究概览
简要总结
In this study, the investigators will compare the effect of magnesium sulphate pretreatment on the onset and duration of intense and deep neuromuscular Block of rocuronium versus Cis-Atracurium and on the period of no response to nerve stimulation in children undergoing elective open abdominal surgeries.
详细描述
Deep neuromuscular blockade is known to improve surgical conditions in procedures such as abdominal or pelvic laparoscopic surgery, laparotomy and laryngeal surgery. In addition, deep neuromuscular blockade enables a reduction in pneumoperitoneal pressure, postoperative pain and the incidence of intra-operative and postoperative adverse events. Correspondingly, the use of deep neuromuscular blockade is increasing, and for its maintenance neuromuscular monitoring is essential; the use of neostigmine may also be helpful in achieving a rapid recovery. Magnesium sulphate has gained prominence as an adjuvant drug in multimodal anesthesia and pain medicine. It has several clinical indications, including attenuation of the adrenergic response to tracheal intubation and improved peri-operative analgesia. Magnesium sulphate also enhances the action of non-depolarizing neuromuscular blocking drugs, resulting in potentiation of neuromuscular blockade (NMB).The site of magnesium potentiation of neuromuscular blocking drugs is the motor end plate, where magnesium reduces the release of prejunctional acetylcholine, thereby decreasing the muscle membrane excitability. However, limited data exist concerning the effect of magnesium sulphate on the duration of deep or intense NMB and on the period of no response to nerve stimulation. In this study, the investigators will compare the effect of magnesium sulphate pretreatment on the onset and duration of intense and deep neuromuscular Block of rocuronium versus Cis-Atracurium and on the period of no response to nerve stimulation in children undergoing elective open abdominal surgeries.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The dose of the administered muscle relaxants will be given by an investigator not included in the study.
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age group 2-12 years old
- •Both genders
- •Children who will be scheduled to undergo elective laparoscopic surgeries.
- •Patients with American Society of Anesthesiologist physical status classification of 1 or 2-
排除标准
- •Patients who are beyond the selected age group.
- •Patients on medications that interfered with muscle activity.
- •Allergy to medications used in this study.
- •Neuro-muscular diseases.
- •Renal or hepatic impairment.
- •Hypermagnesemia (>2.5 mmol) or hypomagnesemia (<1.7 mmol).
- •Parental refusal to participate in the study
研究组 & 干预措施
Cis/atracurium/saline placebo
- The patients will receive 100 ml saline 0.9% at an infusion rate 5 ml/min-1) administered 20 min. before induction of anesthesia.
- cisatracurium will be administered for intubation at a dose of 0.15 mg/kg IV and Maintenance at a dose of 0.03 mg/kg IV
干预措施: Cis-Atracurium (Drug)
Cis-Atracurium/MgSO4
- The patients will be pretreated with magnesium sulphate infusion (30 mg kg-1, total volume 100 ml, infusion rate 5 ml min-1) 20 min. before induction of anesthesia.
- Cis-Atracurium will be administered at 0.1-0.15 mg/kg IV bolus for intubation and maintenance at a dose of 0.03 mg/kg iv on fixed intervals.
干预措施: MgSO4 (Drug)
Cis-Atracurium/MgSO4
- The patients will be pretreated with magnesium sulphate infusion (30 mg kg-1, total volume 100 ml, infusion rate 5 ml min-1) 20 min. before induction of anesthesia.
- Cis-Atracurium will be administered at 0.1-0.15 mg/kg IV bolus for intubation and maintenance at a dose of 0.03 mg/kg iv on fixed intervals.
干预措施: Cis-Atracurium (Drug)
结局指标
主要结局
The time of no response to nerve stimulation (seconds)
时间窗: Intraoperative
Neuromuscular monitoring will be performed using acceleromyography with the TOF-Watch SX (Organon Ireland Ltd, Dublin, Ireland). Period of no response will be defined as the time period with no response to TOF stimulation (intense and deep NMB).
次要结局
- Duration of deep NMB (seconds)(Intraoperative)
- NMB onset time (in seconds).(Intraoperative.)
- The duration of moderate NMB (seconds)(Intraoperative.)
研究者
Hala Saad Abdel-Ghaffar
Principal Investigator
Assiut University