The Effect of Different Altitude Levels on Spinal Anesthesia in Cesarean Section Surgery; Comparison of Anesthesia Parameters and Hemodynamic Changes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Body max index
研究概览
简要总结
The aim of the researchers in this prospective study is to determine the differences, if any, in terms of anesthetic parameters among pregnant women who live at different altitudes and undergo cesarean section under neuraxial anesthesia under elective conditions and to contribute to the literature.
详细描述
Increased intra-abdominal pressure during pregnancy increases the pressure in the epidural and spinal space and causes enlargement of the epidural veins. This may lead to easier increases in the anesthetic blockage level. For this reason, it is necessary to use the lowest possible dose of local anesthesia in these individuals compared to normal healthy individuals.
The literature on the effect of altitude difference on central neuraxial block is limited. Based on studies showing changes in CSF volume and content in hypoxic conditions, According to the researchers, with the same amount of local anesthetic, the duration of sensory and motor blockade at sea level is thought to be equal to or longer than in mid-high regions.
This study will be carried out among pregnant women who live in the city center at 3 different altitudes [0-10 m (Giresun), 810 m (Çorum), 1725 m (Van)] and undergo cesarean section under elective conditions. It will be performed in a multicenter, prospective, controlled, randomized manner in order to determine the differences, if any, among these pregnant women in terms of anesthetic parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •18-40 years old
- •Pregnant women 160-170 centimeters tall
- •Be residing in the place of participation for at least 1 month
排除标准
- •>ASA 2 pregnant women
- •Contraindicated for spinal anesthesia, such as infection or coagulation disorder at the needle insertion site
- •Pregnant women to be taken under emergency conditions
结局指标
主要结局
Body max index
时间窗: preoperative period
kg/m2
the highest level of sensory block
时间窗: during the surgery
dermatome level
American Society of Anesthesiologists (ASA)
时间窗: preoperative period
ASA I and II
The number and duration of spinal anesthesia applications
时间窗: during the surgery
second
age
时间窗: preoperative period
18-40 age frame
mean arterial pressure
时间窗: during the surgery
mmHg
the duration of sensory block formation in the T6 dermatome
时间窗: during the surgery
second
the time to reach each score of the MB(Modified bromage scale) scale 1-2-3
时间窗: during the surgery
second
the duration of the operation (time from the beginning of the surgical incision to the completion of the surgery)
时间窗: during the surgery
minute
heart rate
时间窗: during the surgery
beats/min
次要结局
- postoperative headache parameter(postoperative first and 7. day)
- postoperative nausea and vomiting parameter(postoperative first 24 hour)
- postoperative block parameters(postoperative first 24 hour)
研究者
Dilek Yeniay
Anesthesiology and Reanimation physician
Giresun University