Factors Influencing Bradycardia During Spinal Anesthesia in Obstetric Patients Undergoing Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 289
- 试验地点
- 1
- 主要终点
- structured questionnaire
研究概览
简要总结
The study titled "Factors Influencing Bradycardia During Spinal Anaesthesia in Obstetric Patients Undergoing Caesarean Section"" aims to investigate the causes and patterns of bradycardia in pregnant women receiving spinal anesthesia during cesarean deliveries. Bradycardia, defined as a heart rate below 60 beats per minute, is a known complication of spinal anesthesia, often resulting from sympathetic blockade and unopposed parasympathetic activity. This condition may lead to hypotension, decreased cardiac output, and compromised fetal oxygenation.
详细描述
The research seeks to enhance the understanding of both patient-specific and procedural risk factors, contributing to improved clinical management, safer anesthesia practices, and better maternal-fetal outcomes. Ethical approval and informed consent protocols are included to ensure participant safety and data confidentiality.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obstetric patients aged 18-40 years.
- •Undergoing elective or emergency cesarean sections under spinal anesthesia.
- •Classified as ASA Physical Status I or II (relatively healthy or with mild systemic disease).
- •Provided informed consent (either by the patient or legal guardian).
排除标准
- •Patients with pre-existing cardiac conditions (e.g., arrhythmias, conduction abnormalities).
- •Patients taking medications that affect heart rate, such as beta-blockers or calcium channel blockers.
- •Patients with contraindications to spinal anesthesia (e.g., coagulopathy, infection at the injection site).
- •Those undergoing combined spinal-epidural or general anesthesia.
- •Patients with incomplete medical records or unable to provide informed consent.
结局指标
主要结局
structured questionnaire
时间窗: 12 Months
1. Section A: Demographic and Baseline Information Age, weight, height, gestational age, parity, medical history, medications. 2. Section B: Anesthetic and Surgical Details Indication for cesarean (elective/emergency), baseline heart rate and BP, type/dose of anesthetic, sensory block level, fluid administration, blood loss. 3. Section C: Intraoperative Hemodynamic Events Occurrence of bradycardia (HR \< 60 bpm), lowest HR, time to bradycardia, associated hypotension, interventions used, maternal symptoms. 4. Section D: Neonatal Outcomes Apgar scores at 1 and 5 minutes, NICU admission and reasons. Scoring: There is no numerical scoring system described. Instead: Responses are mostly categorical or numerical entries (e.g., Yes/No, HR value, BP value, Apgar score).
次要结局
未报告次要终点
研究者
Muhammad Naveed Babur
Principal Investigator
Superior University