Strategy to Calculate Magnesium Sulfate Dose in Obese Patients. A Randomized and Blind Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Magnesium blood concentration at the preset timepoints.
研究概览
简要总结
Magnesium sulfate has been applied in various situations due to actual or potential benefits related to neuroprotection, treatment of eclampsia/pre-eclampsia, arterial hypertension, adrenergic reflex under laryngoscopy/intubation and, shivering, nausea and vomiting, among others. In anesthesia it has been useful as an analgesic adjuvant; however, the method to calculate the dose of magnesium sulfate in obese population is unclear. The objective of this project is to compare two methods of dose calculation based either on the real weight or corrected ideal weight.
详细描述
Magnesium sulfate has been applied in various situations due to actual or potential benefits related to neuroprotection, treatment of eclampsia/pre-eclampsia, arterial hypertension, adrenergic reflex under laryngoscopy/intubation and, shivering, nausea and vomiting, among others. In anesthesia it has been useful as an analgesic adjuvant; however, the method to calculate the dose of magnesium sulfate in obese population is unclear. The objective of this project is to compare two methods of dose calculation based either on the real weight or corrected ideal weight.
Main objective: To determine the optimum strategy to safely and effectively obtain the value of magnesium concentration in the blood of obese population.
Secondary objectives: To evaluate postoperative analgesia and the pharmacokinetic profile of neuromuscular blocker used in each group.
Hypothesis: The null hypothesis is that no matter which method we use to calculate the magnesium sulfate dosage, the blood magnesium concentration will be the same. The alternative hypothesis is that magnesium sulfate dosage based on the patient's actual weight generates higher concentrations of magnesium than that required for postoperative analgesia, as compared with dosage based on that corrected ideal weight of the patient.
Trial design: this is a prospective, controlled, randomized and double-blind clinical trial.
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
The anesthesiologist in charge of randomization will number 75 opaque envelopes and insert a card in each with the corresponding information of the group (according to the lottery) and the medication to be administered. Another anesthesiologist in charge of preparing the blind solution alone will open the envelope. Both of these investigators, as well as the anesthesiologist providing anesthesia and the anesthesiologist in charge of data evaluation will not participate in any of the other steps of the trial. The patients will be blinded to their own treatment group.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 60 year-old
- •body mass index > 30 kg/m²
- •American Society of Anesthesiologists score < III.
排除标准
- •Allergy to any medications of the trial
- •refusal to participate or sign the consent form
- •any global diagnosed neuromuscular disorder
- •cardiac conduction blockade higher than atrioventricular block II
- •use of illicit drugs, use of calcium channel blockers
- •creatinine > 2 mg/dl.
研究组 & 干预措施
Placebo group
Patient will be administered saline solution followed by venous general anesthesia.
干预措施: Placebo group (Drug)
Magnesium sulfate through real weight group
Patient will be administered magnesium sulfate 40 mg/kg of the patient's actual weight followed by venous general anesthesia.
干预措施: Magnesium sulfate through real weight group (Drug)
Magnesium sulfate through ideal corrected weight group
Patient will be administered magnesium sulfate 40 mg/kg of the patient's ideal corrected weight followed by venous general anesthesia.
干预措施: Magnesium sulfate through ideal corrected weight group (Drug)
结局指标
主要结局
Magnesium blood concentration at the preset timepoints.
时间窗: Four hours
Comparison of the magnesium concentration (mg/ml) in blood between groups
次要结局
- Opioid consumption(Four hours.)
- Time to recovery from neuromuscular blockade(During recovery time (just after the end of surgery))
研究者
Joaquim Edson Vieira
Associate professor
University of Sao Paulo General Hospital