Comparison of Calcium Gluconate and Phenylephrine for prevention of post spinal hypotension in parturients undergoing elective caesarean section.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To compare the incidence and severity of post-spinal hypotension between intravenous Calcium Gluconate and Phenylephrine in parturients undergoing elective caesarean section, using serial systolic blood pressure measurements. Hypotension will be defined as SBP less than 90 mm Hg or more than or equal to 20% decrease from baseline.
研究概览
简要总结
Post-spinal hypotension is a frequent complication during caesarean section, associated with maternal and fetal morbidity. Phenylephrine is the standard vasopressor for prophylaxis but may cause reflex bradycardia and reduced cardiac output. Calcium gluconate, through vasoconstriction, positive inotropy, and volume expansion, may offer a safer alternative.
This study is a prospective, randomized, double-blind, comparative interventional trial conducted on 70 ASA II/III term parturients undergoing elective caesarean section under subarachnoid block at VMMC & Safdarjung Hospital, New Delhi. Participants will be randomly allocated into two groups: Calcium Gluconate group (10 mL of 10% calcium gluconate in 40 mL NS infused over 15 minutes) and Phenylephrine group (50 mcg phenylephrine in 49 mL NS infused over 15 minutes).
The primary outcome is incidence of post-spinal hypotension. The secondary outcomes include additional vasopressor requirement, intraoperative blood loss, maternal hemodynamic parameters, neonatal Apgar scores, umbilical artery pH and ionized calcium levels.
The study duration is 18 months, with a total sample size of 70 (35 per group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Term parturients between 18-40 years of age belonging to American Society of Anesthesiologists (ASA) Grade II and III scheduled to undergo elective caesarean section under subarachnoid block
- •Height between 150-170 cms
- •BMI less than 30 kg/m2
- •Singleton pregnancy.
排除标准
- •Patients with-
- •Contraindications for regional anaesthesia like allergy to local anaesthetic drugs, local site infection or with coagulopathies
- •Inability to communicate effectively/ known psychiatric illness
- •Antepartum Haemorrhage and Pre-eclampsia/essential hypertension.
结局指标
主要结局
To compare the incidence and severity of post-spinal hypotension between intravenous Calcium Gluconate and Phenylephrine in parturients undergoing elective caesarean section, using serial systolic blood pressure measurements. Hypotension will be defined as SBP less than 90 mm Hg or more than or equal to 20% decrease from baseline.
时间窗: Every 2 minutes for 10 minutes, then every 5 minutes until end of surgery
次要结局
- Neonatal Outcomes(APGAR Scores)
- Umbilical Artery Blood gas analysis to assess fetal well being and effects of maternal drug intervention on the neonate
- Maternal Serum Calcium Levels
- Hemodynamic Parameters which include
- Estimate intraoperative blood loss using gravimetric and visual method.
- Level of maximum Sensory blockade and(Level of Motor blockade using Modified Bromage Scale)
研究者
Dr Radhika Thakur
VMMC and Safdarjung hospital