An Analysis of Risk Factors and Implementation of Strategies to Prevent Nausea and Vomiting in Patients Undergoing Regional Anesthesia for Caesarean Section
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Postoperative nausea and vomiting 6 hours after caesarian section.
研究概览
简要总结
Post-operative nausea and vomiting (PONV) in women undergoing subarachnoid anesthesia for Caesarean section is an important clinical problem. The aim of this study is to compare the effectiveness of oral carbohydrate loading to standard pre-operative fasting in patients undergoing elective cesarean section on the incidence and severity of PONV and biochemical parameters indicating ketosis.
详细描述
Post-operative nausea and vomiting (PONV) in women undergoing subarachnoid anesthesia for Caesarean section is an important clinical problem. Known mechanisms underlying PONV are based on prolonged fasting, hypotension due to concomitant sympatholysis during anesthesia, bradycardia due to increased vagal tone, visceral stimulation during surgery and intrathecal administered opioids. However, the identification of patients exposed to this problem and appropriate perioperative preparation is of key importance. An analysis of risk factors for postoperative nausea and vomiting in patients undergoing elective cesarean section under spinal anesthesia is of major clinical importance. The aim of this study is a comparison of the effectiveness of oral carbohydrate loading strategy as compared with standard pre-operative fasting in patients undergoing elective cesarean section under spinal anesthesia on the incidence and severity of PONV and biochemical parameters indicating ketosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age >=18 years.
- •Scheduled for an elective cesarean section.
- •Uncomplicated pregnancy.
- •Planned for spinal anesthesia.
- •ASA I or ASA II.
排除标准
- •History of diabetes.
- •History of gastro-intestinal reflux (GERD).
- •Unable or unwilling to sign an informed consent.
- •Contraindications to spinal anesthesia.
- •Contraindication to Oral carbohydrate formula.
研究组 & 干预措施
Preoperative oral carbohydrate load
6 hours for solid food and 2 hours for liquids + oral carbohydrate preparation 2 hours prior to surgery.
干预措施: preoperative oral carbohydrate, preOp (Dietary Supplement)
Standard preoperative fasting
6 hours for solid food and 2 hours for liquids.
结局指标
主要结局
Postoperative nausea and vomiting 6 hours after caesarian section.
时间窗: 6 hours
The Postoperative Nausea and Vomiting (PONV) Intensity Scale 6 hours after caesarian section. Scale range: 0-50. The scale measures PONV intensity, where a score ≥50 defined clinically important PONV: PONV Intensity Scale=severity of nausea (1=mild, 2=moderate, 3=severe)×pattern of nausea (1=varying, 2=constant)×duration of nausea (in hours).
Postoperative nausea and vomiting 24 hours after caesarian section.
时间窗: 24 hours
The Postoperative Nausea and Vomiting (PONV) Intensity Scale 24 hours after caesarian section. Scale range: 0-50. The scale measures PONV intensity, where a score ≥50 defined clinically important PONV: PONV Intensity Scale=severity of nausea (1=mild, 2=moderate, 3=severe)×pattern of nausea (1=varying, 2=constant)×duration of nausea (in hours).
次要结局
- Time to first peristalsis.(24 hours)
- Time to first bowel movement.(24 hours)
- Concentration of serum lactate in serum.(0 hours)
- Concentration of beta-hydroxy-butiric acid in serum.(0 hours)
- Insulin resistance factor (HOMA-IR).(0 hours)
- Concentration of isoprostane in urine.(0 hours)
研究者
Katarzyna Kotfis
Primary Investigator
Pomeranian Medical University Szczecin