Effects of Magnesium Sulphate on Sugammadex Reversal of Rocuronium Induced Blockade in Gynaecology Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- TOF 0.9 Achieving Time
研究概览
简要总结
Background: The aim of this prospective study was to evaluate the effect of magnesium on the reversal of rocuronium-induced neuromuscular block by sugammadex.
Methods: Eighty patients, aged 18 to 60 years, American Society of Anesthesiologists I-II, undergoing elective gynecological surgery were enrolled. Anaesthesia was induced with propofol and fentanyl and was maintained with 60% nitrous oxide and Oxygen in sevoflurane. The magnesium group received 50 milligram/kilogram (mg/kg) Magnesium intravenous (iv) as a bolus and 15 mg/kg/hour by continuous infusion until the completion of surgery. The placebo group received the equivalent volume of isotonic saline. For intubation, 0.6 mg/kg rocuronium was administered and 0.1 mg/kg was added when Train of four (TOF) counts reached 1 or more during the procedure. At the end of the surgery at a TOF count of 1, 4 mg/kg sugammadex iv was administered. Patients were observed until a TOF ratio of 0.9 was achieved. Patient-controlled analgesia with intravenous morphine was used postoperatively.
详细描述
Inclusion criteria:
- American Society of Anesthesiologists physical status I or II
- 18-60 years of age
- undergoing elective gynecological surgery
- requiring endotracheal intubation
Exclusion criteria:
- Patients who had body mass index > 35
- gastroesophageal reflux
- a history of allergy
- used medication known to interact with the drugs being used in this trial
- who experienced expected or unexpected difficulty during intubation or ventilation
- had neuromuscular disease
- hepatic or renal insufficiency
- pregnant
- were American Society of Anesthesiologists III or IV
- had a family history of malignant hyperthermia
- detection if low or high control plasma magnesium levels
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients
- •American Society of Anesthesiologists (ASA) physical status I or II
- •18-60 years of age who were undergoing elective gynecological surgery
- •requiring endotracheal intubation were enrolled in this prospective study.
排除标准
- •Patients who had body mass index > 35
- •gastroesophageal reflux
- •a history of allergy
- •used medication known to interact with the drugs being used in this trial
- •who experienced expected or unexpected difficulty during intubation or ventilation
- •had neuromuscular disease
- •hepatic or renal insufficiency
- •were pregnant
- •had a family history of malignant hyperthermia
- •detection if low or high control plasma magnesium levels
研究组 & 干预措施
sugammadex and placebo
sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery
干预措施: placebo (Drug)
sugammadex and placebo
sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery
干预措施: sugammadex (Drug)
sugammadex and magnesium sulphate
sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery
干预措施: Magnesium Sulphate (Drug)
sugammadex and magnesium sulphate
sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery
干预措施: sugammadex (Drug)
结局指标
主要结局
TOF 0.9 Achieving Time
时间窗: end of the surgery
次要结局
- Rocuronium Onset Time(during the surgery)
- Rocuronium Supplementation(during surgery)
- Postoperative Morphine Consumption(after 12 hour surgery)
研究者
Zehra Ipek ARSLAN
Assistant Professor
Kocaeli University