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临床试验/NCT02883075
NCT02883075已完成不适用

Measurement of Hemodynamic Variables Under Spinal Anesthesia in a Patient Undergoing Cesarean Section With Varied Positioning - a Comparative Study

The University of Texas Medical Branch, Galveston1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2017年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
1
主要终点
Blood pressure

研究概览

简要总结

Multiple studies have compared spinal anesthetic performed supine versus lateral, with varying results, in parturients having elective cesarean section. Needle positioning during spinal placement has also been examined. No positioning techniques have demonstrated definitive superiority for hemodynamic stability.

Investigators propose that following spinal placement in the sitting position if the patient is placed in a lateral position for 90 seconds prior to turning them supine, hemodynamic changes caused by sympathectomy related to the subarachnoid block can be avoided.

This is the first study to examining the influence of position changes after spinal anesthetic placement in the sitting position, which includes hemodynamic variables not previously studied including cardiac output, TPR (total peripheral resistance) and pulse pressure variation (PPV).

详细描述

Cesarean section is chosen when natural spontaneous vaginal delivery is either not possible or when the health of the baby or mother is compromised. Cesarean section may be planned, urgent, or performed emergently when the life of the baby or mother is threatened.

Cesarean section is performed using different anesthetic techniques including: spinal, epidural, combined spinal and epidural, and general anesthesia. Spinal anesthesia is the most common technique chosen due to its relative safety, rapid onset and avoidance of potential complications from general anesthesia. It is the technique of choice for elective cesarean section unless contraindicated. Spinal anesthesia causes sympathetic blockade followed by sensory and motor blockade. Nerve fiber size explains the speed of onset and differential block. The critical moments during spinal anesthesia come as soon as local anesthetic is injected into the subarachnoid space.

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

  • •Parturients undergoing elective cesarean section under spinal anesthesia
  • •Singleton intrauterine pregnancy with appropriate gestational age fetus (AGA) at gestational age 37 to 42 weeks

排除标准

  • •Large for gestational age, small for gestational age, and multiple gestations
  • •Patients with cardiovascular disease like hypertension, etc.
  • •Non-English or non-Spanish speakers
  • •Inadequate or failed blocks and inadvertently high levels of spinal blockade will be dropped from the study
  • •Incarcerated parturients
  • •Expected heavy bleeding (placenta accreta, vascular anomaly, etc.)

研究组 & 干预措施

Supine position

Sham Comparator

Supine position Supine position after placement of spinal anesthetic

干预措施: Supine position (Other)

Right lateral position

Active Comparator

Right lateral position Right lateral after placement of spinal anesthetic

干预措施: Right lateral position (Other)

Left lateral position

Active Comparator

Left lateral position Left lateral after placement of spinal anesthetic

干预措施: Left lateral position (Other)

结局指标

主要结局

Blood pressure

时间窗: Immediately before spinal anesthetic placement through placental delivery

Continuous Blood pressure (mmHg) measurements

Heart rate

时间窗: Immediately before spinal anesthestic placement through placental delivery

Continuous Heart rate (beats per minute) measurements.

次要结局

  • Total vasopressor usage(Spinal anesthetic placement through placental delivery)
  • Non Invasive Cardiovascular measurements: cardiac output(Spinal anesthetic placement through placental delivery)
  • Anti-emetic medication(Number of events spinal anesthetic placement through placental delivery)
  • Incidence of vasopressor usage(Spinal anesthetic placement through placental delivery)
  • Incidence of nausea and vomiting(Number of events spinal anesthetic placement through placental delivery)
  • Non Invasive Cardiovascular measurements: stroke volume(Spinal anesthetic placement through placental delivery)
  • Non Invasive Cardiovascular measurements: TPR (total peripheral resistance)(Spinal anesthetic placement through placental delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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