Intravenous Magnesium Sulfate for the Prevention of Intraoperative Shivering in Parturients Undergoing Cesarean Delivery Under Lidocaine Top-up Via a Pre-existing Epidural Catheter Inserted for Labor Analgesia - A Randomized Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Severity of intraoperative shivering
研究概览
简要总结
Magnesium has been shown to decrease the shivering experienced from neuraxial anesthesia. This study aims to investigate whether magnesium decreases the shivering experienced in parturients undergoing labor epidural anesthesia for Cesarean delivery.
详细描述
Women who have epidurals in place and go on to require a Cesarean delivery typically have their epidurals 'topped-up' with a fast onset local anesthetic to ensure the lower body is fully numb for surgery. This is called an epidural 'top-up'. However, a side effect of epidural top-ups is shivering, which is uncomfortable for the mother and interferes with patient monitoring. Magnesium administration has been shown to decrease shivering in the non-pregnant population. Therefore, in this study the investigators aim to determine if magnesium given prior to an epidural top-up decreases the incidence and severity of shivering in the pregnant population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestational age of ≥37 weeks
- •Women who are ≥ 19 years old
- •Women undergoing Cesarean delivery under lidocaine top-up via a preexisting epidural catheter inserted for labor analgesia
- •American Society of Anesthesiologist (ASA) Physical Status class 1 or 2
排除标准
- •Emergency Cesarean delivery with limited time for informed consent
- •Women who have received MgSO4 prior to study enrollment
- •Indication for alternative mode of anesthesia for Cesarean delivery (e.g., general anesthesia)
- •Medical conditions or medications that could lead to tremor or shivering. (e.g., movement disorder, untreated thyroid disease) or mask tremor or shivering (e.g., beta-blocker, benzodiazepine, anticonvulsants)
- •Active shivering at time of recruitment
- •Inability to read and understand English for the purpose of informed consent
- •Contraindications to receiving MgSO4 (hypersensitivity reactions, respiratory rate <16breaths/min, absent reflexes, urine output <100 mL during the previous 4 hours, renal failure, or hypocalcemia)
- •History of previous postpartum hemorrhage
研究组 & 干预措施
Magnesium sulfate
Magnesium sulfate (MgSO4) infusion will be commenced prior to epidural top-up.
干预措施: Magnesium Sulfate (Drug)
Normal saline
Normal saline infusion will be commenced prior to epidural top-up.
干预措施: Normal Saline (Other)
结局指标
主要结局
Severity of intraoperative shivering
时间窗: Through completion of cesarean surgical procedure (maximum 2 hours)
Severity measured subjectively by anesthesiologist and patient
Incidence of intraoperative shivering
时间窗: Through completion of cesarean surgical procedure (maximum 2 hours)
Incidence measured as shivering present or absent
次要结局
- Total vasopressor(s) dose(Through study completion (maximum 2.5 hours))
- Total utertonic(s) dose(Through completion of cesarean surgical procedure (maximum 2 hours))
- Incidence of hypothermia(Through study completion (maximum 2.5 hours))
- Incidence of hypotension(Through study completion (maximum 2.5 hours))
研究者
Anthony Chau
Clinical Assistant Professor
University of British Columbia