Correlation of preoperative fasting duration with Gastric Ultrasound findings in elective Cesarean deliveries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Qualitative: Perlas grading
研究概览
简要总结
Perioperative aspiration is a major cause of mortality especially among pregnant patients due to their physiological changes. In our country, noncompliance to recommended fasting guidelines is frequently observed and perioperative safety in obstetric cases is compromised by both short and prolonged fasting durations.
The Aim of this study is to find correlation between preoperative fasting durations with gastric ultrasound findings and intraoperative clinical features like intraoperative nausea and vomiting, capillary blood glucose and overall patient discomfort and anxiety.
The objectives are Evaluation of real world fasting practices among parturient scheduled for elective cesarean delivery under spinal anaesthesia. Ensure perioperative obstetric safety and reduce the aspiration risk. To find scopes for refine, revalidate and individualise the current fasting guidelines.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Gestational Age: Non-labouring, term pregnant women (greater than and equal to 37 weeks gestation).
- •Procedure: Scheduled for elective cesarean section under spinal anesthesia.
- •Physical Status: American Society of Anesthesiologists (ASA) physical status II.
- •Body Mass Index (BMI): 18.5–40 kg per m² (ASA II) Fasting Status: Patients who have followed preoperative fasting as per institutional practices.
排除标准
- •Patients in labour.
- •Patients with exaggerated Aortocaval syndrome.
- •Multiple Gestation: Women with multiple pregnancies.
- •Emergency Procedures: Patients requiring emergency cesarean section.
- •Obstetric Complications graded III or beyond: Preeclampsia with severe features, gestational DM with complications or high insulin requirements, a thrombophilic disease requiring anticoagulation, etc.
- •Cases converted to general anaesthesia post spinal anaesthesia failure.
- •Refusal to Participate: Declined or withdrew consent at any stage.
- •Mentally incompetent: unable to provide informed consent.
结局指标
主要结局
Qualitative: Perlas grading
时间窗: Ultrasound scans and its real time assessment will be done 10 minutes before giving spinal anaesthesia in cesarean delivery surgery.
Quantitative: Gastric volume by measuring antral Cross-sectional area.
时间窗: Ultrasound scans and its real time assessment will be done 10 minutes before giving spinal anaesthesia in cesarean delivery surgery.
次要结局
- Intraoperative Nausea & vomiting(Intraoperative symptoms like nausea & vomiting will be assessed every 10 minutes during the surgery.)
- Intraoperative Capillary blood glucose(Capillary Blood Glucose will be assessed once during the surgery at any given point.)
- Intraoperative discomfort & anxiety(Intraoperative symptoms like patient discomfort will be assessed every 10 minutes during the surgery.)
研究者
Dr. Oela Roy
ESI PGIMSR and Hospital Manicktala