The Effect of Prophylactic Magnesium Use in Pregnant Women on Reversal of Neuromuscular Block With Sugammadex:Evaluation With TOF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recovery time
研究概览
简要总结
Magnesium therapy used for seizure prophylaxis in patients with preeclampsia. Magnesium has been shown to prolong the effect of nondepolarizing neuromuscular blocking agents (NMBA) and neostigmine used to reverse the effect of NMBA in general anesthesia . In this study, the investigators aimed to evaluate time from sugammadex injection to Train-of-four ratio 0.9 who receieved magnesium therapy in reversing the effect of neuromuscular blocking agent during the recovery period and the relationship between magnesium level and duration of action of sugammadex
详细描述
Rapid-onset and short-acting agents should be preferred in induction, and full induction doses should be applied since they do not receive premedication and increased volume of distribution. Rapid serial induction and intubation should be performed in pregnancies greater than 20 weeks due to the risk of aspiration. Magnesium potentiates and prolongs the effect of nondepolarizing neuromuscular blocking agents. It is recommended that the TOF value be between 0 and 2 for adequate muscle relaxation in cesarean section anesthesia. In anesthesia induction; thiopental 3-6mg/kg, rocuronium 1mg/kg, and fentanyl 1mcg/kg and dormicum 2mg will administered after the baby birth. Sevoflurane 2-3% and 50% oxygen + 50% air are used for maintenance. If TOF is 0, sugammadex 4mg/kg will be administered to reverse the effect of the muscle relaxant.A blood sample will be taken to measure simultaneous calcium and magnesium values. Patients with a TOF ≥0.9 (gold standard for extubation) or patients will be clinically evaluated and the decision to extubate will be made.
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
It will be evaluated by another investigator (blind) who does not know in which group the patient is using magnesium sulfate during the intraoperative period.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women who are scheduled for cesarean section under general anesthesia (pregnant women who do not use magnesium) and who use magnesium for prophylaxis in preeclampsia.
排除标准
- •Eclampsia,
- •chronic hypertension,
- •connective tissue disorder,
- •muscle disease, neurological problems,
- •thyroid dysfunction,
- •kidney disease, heart disease,
- •patients with severe allergic reaction to the agents to be used,
- •hypovolemia, abruptio placenta, placenta previa,
- •conditions that will prolong the effect of muscle relaxants (drug use ),
- •pregnant women who did not want to be included in the study
研究组 & 干预措施
pregnant women taking magnesium
The patient group who received magnesium as a 4-6 g loading and 2-3 g/h maintenance dose to prevent convulsions in preeclampsia. Pregnant will be operated under general anesthesia
干预措施: pregnant women taking magnesium (Drug)
control group
Pregnant will be operated under general anesthesia
干预措施: Placebo (Drug)
结局指标
主要结局
Recovery time
时间窗: at end of surgery (Postoperative 2 hours)
TOF 0.9 Achieving Time and evaluate the relationship between blood magnesium and calcium level with sugammadex effect.
次要结局
未报告次要终点
研究者
Meryem Onay
assistant professor
Eskisehir Osmangazi University