A Randomized Controlled Trial Comparing the Effectiveness of Different Doses of Ephedrine Infusion in Preventing Maternal Hypotension Following Spinal Anesthesia for Caesarean Section
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of Hypotension in Patients Undergoing Cesarean Section Following Spinal Anesthesia.
研究概览
简要总结
This randomized controlled trial aims to compare the effectiveness of different doses of ephedrine infusion in preventing maternal hypotension following spinal anesthesia in parturients undergoing cesarean sections. The study includes 120 participants, aged 18-40 years, with American Society of Anesthesiologists (ASA) physical status II, who are scheduled for elective cesarean delivery. The primary objective is to determine whether low-dose ephedrine infusions at 1.25 mg/min or 1.5 mg/min effectively reduce the incidence of maternal hypotension, with secondary outcomes assessing the need for rescue ephedrine, incidence of side effects (nausea, vomiting, tachycardia), and neonatal Apgar scores. Researchers will compare three groups-saline, 1.25 mg/min ephedrine, and 1.5 mg/min ephedrine-to evaluate their impact on maternal hemodynamic stability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing cesarean section
- •Self-identified as female
- •American Society of Anesthesiologists (ASA) physical status II
- •Aged between 18 to 40 years
- •Full-term singleton pregnancies planned for cesarean delivery under spinal anesthesia
排除标准
- •Body mass index (BMI) ≥ 40 kg/m²
- •Height less than 145 cm
- •Presence of severe neurological or psychiatric conditions
- •History of pre-eclampsia
- •Severe renal or metabolic disorders
- •Contraindications to spinal anesthesia
- •Antenatal evidence of fetal anomalies
- •Cases with severely compromised fetuses requiring immediate general anesthesia
- •Baseline systolic blood pressure (SBP) less than 90 mm Hg
- •Pregnancy-induced hypertension
- •Refusal to provide written consent
研究组 & 干预措施
Group A who received normal saline immediately after the administration of the
Participants in this group received normal saline immediately after the administration of the subarachnoid block (spinal anesthesia). This group serves as the control group to compare the effectiveness of ephedrine against no pharmacologic intervention
干预措施: Normal Saline (Placebo) (Drug)
Group B who received ephedrine at a dosage of 1.25 mg/min immediately after the subarachnoid block
Participants in this group received ephedrine at a dosage of 1.25 mg/min immediately after the subarachnoid block. This dose is intended to prevent maternal hypotension by maintaining blood pressure during spinal anesthesia.
干预措施: Ephedrine (Drug)
Group C who received ephedrine at a dosage of 1.5 mg/min immediately after the subarachnoid block
Participants in this group received ephedrine at a higher dosage of 1.5 mg/min immediately following the subarachnoid block. This intervention tests whether a slightly higher dose of ephedrine provides better prevention of maternal hypotension without increasing side effects.
干预措施: Ephedrine (Drug)
结局指标
主要结局
Incidence of Hypotension in Patients Undergoing Cesarean Section Following Spinal Anesthesia.
时间窗: Hypotension episodes were monitored and recorded intraoperatively, immediately following the administration of spinal anesthesia until the end of the cesarean section procedure. The time frame for evaluating this outcome was during the surgical procedure
The primary outcome of the study is the incidence of maternal hypotension, defined as a decrease in systolic blood pressure (SBP) by more than 20% from baseline, in patients who received different doses of ephedrine (1.25 mg/min or 1.5 mg/min) or saline infusion following spinal anesthesia for cesarean section.
次要结局
未报告次要终点
研究者
Narottam Jha
Clinical Professor
B.P. Koirala Institute of Health Sciences