跳至主要内容
临床试验/NCT05757999
NCT05757999招募中2 期

Effect of Magnesium Sulphate Pretreatment on Cis-Atracurium Induced Neuromuscular Block and Recovery Characteristics: A Randomized Controlled Trial.

Assiut University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年7月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
100
试验地点
1
主要终点
The duration of the period of no response.

研究概览

简要总结

In this study, the effect of magnesium sulphate on the onset and duration of intense and moderate cis-atracurium induced neuromuscular blocking and on the period of no response to nerve stimulation will be evaluated in patients who will recieve magnesium sulphate (intervention group) and patients who will not recieve magnesium sulphate (comparator group).

详细描述

General anesthesia is a drug-induced reversible state consisting of unconsciousness, amnesia, anti-nociception, and immobility, with maintenance of physiological stability. Balanced general anesthesia, the most common management strategy used in anesthesia care, entails administering a combination of different agents to create the anesthetic state. There is evidence that balanced general anesthesia uses less of each drug than if the drug were administered alone. This approach is believed to increase the likelihood of a drug's desired effects and reduce the likelihood of its side effects. With addition of adjuvants, Alpha-2 adrenoceptor agonists, such as dexmedetomidine, are known to possess amnesic, analgesic, sympatholytic, and antinociceptive properties, and therefore, can reduce the requirement of anesthetics and opioids intraoperatively. Administration of MgSO4 has also shown significant reduction in the perioperative requirement of propofol, opioids, and muscle relaxants. 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.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Allocation numbers will be placed in opaque envelopes and opened by an anesthesiologist (not participating in the study)who will also prepare the study solutions. The solutions used in the study are similar in physical appearance and an investigator not included in the study will prepare the solutions.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age group 18-60 years old
  • Both genders
  • Patients who will be scheduled to undergo elective otorhinolaryngological surgery.
  • Patients with BMI between 18.5 and 24.9 Kg/m
  • Patients with American Society of Anesthesiologist physical status classification of 1 or 2

排除标准

  • Patients who are less than 18 years old or more than 60 years old.
  • Patients on medications that interfered with muscle activity.
  • Allergy to medications used in this study.
  • Pregnancy or suspected pregnancy.
  • Neuro-muscular diseases.
  • Renal or hepatic impairment.
  • Hypermagnesemia (>2.5 mmol) or hypomagnesemia (<1.7 mmol).
  • Patients refusing to study

研究组 & 干预措施

MgSo4

Active Comparator

A magnesium sulphate infusion (60 mg kg-1, total volume 100 ml, infusion rate 10 ml min-1) 10 min. will be administered before induction of anesthesia

干预措施: Magnesium Sulphate (Drug)

Saline Placebo

Placebo Comparator

an intravenous 0.9% saline infusion (total volume 100 ml, infusion rate 10 ml min-1) 10 min. will be administered before induction of anesthesia.

干预措施: Saline (Drug)

结局指标

主要结局

The duration of the period of no response.

时间窗: Intraoperative.

The effect of pretreatment with magnesium sulphate on the duration of the period of no response will be measured with the TOF-Watch SX (Organon Ireland Ltd, Dublin, Ireland). The ulnar nerve near the wrist will be stimulated and the activity of the adductor pollicis (thumb) muscle will be recorded.

次要结局

  • The duration of intense neuromuscular block (minutes)(Intraoperative)
  • The duration of deep neuromuscular block(Intraoperative.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hala Saad Abdel-Ghaffar

Professor

Assiut University

研究点 (1)

Loading locations...

相似试验