Spinal Anesthesia for Cesarean Delivery: Bupivacaine With or Without Fentanyl
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- The primary outcome is the maximal degree of abdominal sensation felt by the patient during surgery.
研究概览
简要总结
The safest form of anesthesia for Cesarean section is a spinal anesthetic. All spinal anesthetics contain a local anesthetic and/or a narcotic. A drug named bupivacaine is the most commonly used local anesthetic in spinal anesthetics for Cesarean deliveries in North America. Another drug named fentanyl is the most commonly used narcotic. This study will look at whether a spinal anesthetic with 15mg of bupivacaine alone will be the same as a spinal anesthetic with 12mg of bupivacaine and 15ug of fentanyl.
详细描述
There have been many studies looking at different doses and combinations of bupivacaine and fentanyl but there is no agreement among anesthesiologists as to the best combination of drugs.
The main problem with bupivacaine is that it causes hypotension (low blood pressure). When fentanyl is added to bupivacaine, a lower dose of bupivacaine can be used so that there is less of a fall in blood pressure. The main problem with fentanyl is itchiness and sleepiness. In the case of an emergency Cesarean section, the extra time needed to draw-up and administer a second medication may make a difference to the health of the baby.
Our goal is to determine whether high dose bupivacaine (15mg) alone will produce spinal anaesthesia for cesarean delivery equivalent to 12mg of intrathecal hyperbaric bupivacaine in combination with 15ug of intrathecal fentanyl.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy patients (ASA 1 or 2)
- •BMI < 40
- •height between 5 & 6 feet
排除标准
- •parturients with pregnancy induced hypertension or preeclampsia
- •parturients with significant cardiac, renal or other organ-system disease which preclude choice of spinal anesthesia
- •emergency delivery
- •triplet or greater multiple gestation
研究组 & 干预措施
1
Bupivacaine alone
干预措施: Bupivacaine (Drug)
2
Bupivacaine plus Fentanyl
干预措施: Bupivacaine, fentanyl (Drug)
结局指标
主要结局
The primary outcome is the maximal degree of abdominal sensation felt by the patient during surgery.
时间窗: 1 hour
次要结局
- Time to regression of block (minutes)(4 hours)
- Speed of onset of block to T4 dermatome (minutes), as well as highest level of block (dermatomal level) and degree of motor block (Bromage scale)(30 minutes)
- The degree of patient discomfort will be evaluated using a 10 cm linear visual analog scale (VAS).(1 hour)
- The amount of additional IV analgesia administered during the intraoperative period.(1 hour)
- Duration of analgesia (hours)(24 hours)
- Incidence of side effects: Intraoperative pruritus, nausea and vomiting in the absence of hypotension, somnolence, shivering, euphoria or dysphoria and respiratory depression will be evaluated.(2 hours)
- Dose of vasopressor(s) given during surgery(1 hour)
- Lowest Mean Arterial Pressure during surgery (=2/3 diastolic pressure + 1/3 systolic pressure).(1 hour)
- Patient satisfaction. A number of questions answered on a Likert Scale will be asked post-Cesarean section.(15 minutes)
- Neonatal arterial blood gas results (pH) and 1 and 5-minute APGAR scores (1 - 10) will be recorded(10 minutes)