Prospective Observational Study, Maternal Effects of Magnesium Sulphate for Neonatal Neuroprotection in Women Having Cesarean Section Under Neuraxial Anesthesia
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Maximal Expiratory Pressure
研究概览
简要总结
Magnesium is a treatment for mothers to protect brains of babies born early. This study investigates combined effects of magnesium and spinal or epidural anesthesia on mothers having cesareans.
The investigators will use a scoring system to measure sedation and devices that subjects breath in and out of to measure breathing strength.
The investigators hypothesize the combination of magnesium and anesthesia will reduce breathing strength and cause sedation.
This is an observational study comparing those having magnesium and anesthesia with those just having anesthesia. Routine medical care will not be altered.
Results will hopefully allow anesthesiologists to provide better patient care.
详细描述
- Purpose
Neonatal neuroprotection is a new indication for magnesium. Meta-analysis of the available literature suggests beneficial neonatal outcomes, but the direct effects on maternal health have not been studied. Unwanted effects of magnesium therapy such as sedation and respiratory insufficiency may be potentiated by neuraxial anesthesia placing the mother at risk of morbidity. 2. Hypothesis or Aim
Magnesium causes sedation and muscle weakness, which potentiates effects of neuraxial anesthesia, increases respiratory insufficiency, reduces cough effectiveness and increases pulmonary aspiration risk. We hypothesise that compared to the control group, the group receiving magnesium will have a reduced Maximal Expiratory Pressure (MEP) by ≥15 cmH2O, or a 10% higher incidence of a composite sedation score ≤ 3. 3. Justification for the study
There is strong evidence in the medical literature to support the current guidelines and practice to treat parturients presenting for pre-term delivery, less than 34 weeks with magnesium. The presumed benefits are a reduction in the incidence and functional motor deficit from cerebral palsy, and possibly reduction in infant mortality. Treatment with magnesium represents the current accepted practice and level of care.
Approximately 50% of these pre-term patients will require neuraxial anesthesia to enable cesarean section, using either intrathecal or epidural techniques. There are potential cumulative side effects from neuraxial anesthesia and magnesium but no studies have been done to examine this.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Delivering by cesarean section at less than 34 weeks gestational age (maximum 33 weeks and 6 days).
- •Singleton or multiple pregnancy
- •o There is potentially greater intra-abdominal pressure associated with multiple pregnancies, which may affect anesthetic block height by increasing blood volume in epidural blood vessels. It may also increase the risk of basal atelectasis and will affect respiratory mechanics to a greater extent. We plan to undertake sub-group analysis to test this effect.
- •Primiparous or multiparous
- •English-speaking
- •Undergoing cesarean section with neuraxial anesthesia (intrathecal, epidural or combined spinal epidural [CSE]).
- •Parturients response may not be identical to the different neuraxial techniques, e.g. the degree of respiratory motor blockade exhibited or onset of opioid effect. Therefore we plan to undertake sub-group analysis to test this effect.
排除标准
- •Illegal, non-prescription drug use within the last year
- •Psychiatric disorder treated with medication within the last year
结局指标
主要结局
Maximal Expiratory Pressure
时间窗: 3 minutes for each of 5 tests over 2 hours
We consider 15 cmH20 difference in MEP to be clinically significant.
Composite sedation score
时间窗: 30 seconds for each of 6 tests over 2 hours
A composite score of ≤3 (at any data collection point). This implies one of the following criteria: * Subject responds only after name is spoken loudly or repeatedly * Speech is slurred or slow * Marked relaxation of facial expression * Both eyes are glazed with marked ptosis. We judge this degree and incidence of sedation to be clinically significant. It would certainly be sufficient to interfere with maternal interaction with the newborn, would likely affect maternal memory of the event, and would place the mother at risk of potential airway compromise and respiratory insufficiency.
次要结局
- To compare the following sedation measurements(30 seconds for each of 6 tests over 2 hours)
- To compare the following respiratory measurements(3 minutes for each of 5 tests over 2 hours)
研究者
James Brown
Principle Investigator
University of British Columbia