NCT03716076已完成4 期
The Effect of Carbetocin Dose on Dispersion of Myocardial Repolarization in Healthy Parturients Scheduled for Elective Cesarean Delivery Under Spinal Anesthesia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Tp-e
研究概览
简要总结
Relationship between carbetocin dose on transmural dispersion of repolarization (TDR).
详细描述
Carbetocin is a uterotonic used to prevent postpartum hemorrhage. Although it has been proven to be completely safe, little is known about its effects on the electrical activity of the heart. The investigators aim to determine its effect on myocardial repolarization dynamics
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, 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
- •Pregnant patients ≥ 36 weeks gestation, for elective Cesarean delivery under neuraxial anesthesia
- •American Society of Anesthesiologists (ASA) class 2
- •Patients ≥ 19 years of age
排除标准
- •Long QT syndrome
- •Cardiac disease or rhythm abnormalities
- •Family history of long QT syndrome or abnormal cardiac conduction
- •Currently taking medication that is known to prolong the QT interval
- •Women who are high risk for uterine atony as outlined in SOGC
- •Known allergic reaction or hypersensitivity to Carbetocin or any other oxytocin homologue
- •Patients who are unable to give informed consent because of a language barrier as the study team only speaks English and will be unable to complete consent process and study procedure appropriately.
研究组 & 干预措施
Participant receives 50 mcg of carbetocin post-delivery.
Experimental
Participant receives 50 mcg of carbetocin post-delivery.
干预措施: Carbetocin (Drug)
Participant receives 100 mcg of carbetocin post-delivery.
Experimental
Participant receives 100 mcg of carbetocin post-delivery.
干预措施: Carbetocin (Drug)
结局指标
主要结局
Tp-e
时间窗: 5 minutes post-carbetocin administration
Time interval between peak and end of T-wave (Tp-e)
次要结局
- Tp-e 5 Min Post-spinal(5 minutes after administration of spinal anesthesia)
- QTc at 5 Min(5 min post-carbetocin administration)
- QTc 10 Min(10 minutes post-carbetocin administration)
- Tp-e at 10 Min(10 minutes post-carbetocin administration)
- QTc 5 Min Spinal(5 min post-administration of spinal anesthesia)
- Arrhythmia(perioperatively, typically ranging 30 minutes-1 hour)
研究者
Anthony Chau
Clinical Assistant Professor
University of British Columbia
研究点 (1)
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