Hemodynamic effects of Oxytocin and Carbetocin during elective lower segment cesarean section under spinal anesthesia: a double blinded randomized controlled study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare changes in maternal hemodynamic parameters (heart rate, systolic and diastolic blood pressure, mean arterial pressure, ST index and O2 saturation) with use of oxytocin and carbetocin in elective lower segment caesarean section.
研究概览
简要总结
This study is a randomized, double blinded, parallel group, single centre trial comparing the hemodynamic effects of Oxytocin and Carbetocin in pregnant ladies undergoing an elective lower segment cesarean section under spinal anesthesia that will be conducted in one centre in India.
Post partum haemorrhage (PPH) due to uterine atony is one of the leading cause of maternal mortality and morbidity globally. Uterotonics are recommended for use in active management of the third stage of labour to prevent PPH. Oxytocin is the recommended first-line uterotonic for preventing and treating PPH. Carbetocin, a heat stable, long acting oxytocin analogue is also recommended for PPH prevention.
Oxytocin is a synthetic cyclic peptide form of the naturally occurring posterior pituitary hormone. It binds to oxytocin receptors in the uterine myometrium, stimulating contraction of the uterine smooth muscle by increasing the sodium permeability of uterine myofibrils. Intravenous administration of oxytocin has almost immediate action with peak concentration after 30 minutes and has a half-life of 1–6 minutes. Its clinical indications are induction of labour, augmentation of labour and prevention and treatment of PPH.
Carbetocin is a long-acting synthetic analogue of oxytocin with agonist properties. It binds to oxytocin receptors in the uterine smooth muscle, resulting in rhythmic contractions, increased frequency of existing contractions and increased uterine tone. As an intravenous bolus injection it causes sustained uterine contractions within 2 minutes, lasting for about 6 minutes and followed by rhythmic contractions for 60 minutes. It has half-life of 40 minutes. Clinical indication of carbetocin is prevention of PPH.The hemodynamic effects of oxytocin bolus consist of brief hypotension and tachycardia due to systemic vasodilation. Carbetocin, an oxytocin derivative exerts its effect by same molecular mechanism. Currently carbetocin in dose of 100 mcg bolus is routinely used for prevention of PPH. Clinical trials have been done to compare the adverse effects of bolus administration of both the drugs.
There is limited data available to compare the hemodynamic alteration and adverse effects of oxytocin and carbetocin given as infusion. This study is aimed to compare the hemodynamic alterations and side effects of both drugs when given as infusion over 10 minutes with hypothesis that carbetocin and oxytocin given as infusion will cause less cardiovascular side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Healthy pregnant woman under going elective lower segment cesarean section at term under spinal anesthesia concerning to be part of study.
- •Patients aged between 18 to 35 years of age.
排除标准
- •Women with known sensitivity to heat-stable carbetocin or oxytocin
- •Pregnancy with high risk of PPH
- •Pregnancy with other comorbidities.
结局指标
主要结局
To compare changes in maternal hemodynamic parameters (heart rate, systolic and diastolic blood pressure, mean arterial pressure, ST index and O2 saturation) with use of oxytocin and carbetocin in elective lower segment caesarean section.
时间窗: After drug administration, hemodynamic parameters will be recorded at 0, 1, 3, T5, T10, T15, and T30 mins.
次要结局
- To compare the incidence of intraoperative & postoperative feeling of warmth, chest pain, shortness of breath, palpitations, flushing, headache, nausea/ vomiting & chest discomfort.(Patient will be assessed at 10,20,30, 60 minutes post operatively.)
- To compare uterine tone & need of additional uterotonics with use of oxytocin & carbetocin.(Uterine tone will be assessed after 20 minutes of drug administration.)
研究者
Silmi N Abraham
St John’s medical college hospital