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临床试验/NCT03517683
NCT03517683已完成不适用

A Randomized Clinical Trial for the Influence of Injection Rate of Intrathecal Mixture of Local Anesthesia on Hypotension in Cesarean Section

Makassed General Hospital1 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2018年4月15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
159
试验地点
1
主要终点
Incidence of hypotension

研究概览

简要总结

Hypotension is the most common complication of neuraxial anesthesia in obstetric patients and its prevalence in cesarean section is about 50-90%. Maternal hypotension causes unpleasant symptoms such as nausea, vomiting, loss of consciousness, respiratory depression, and cardiac arrest. Hypotension may reduce placental perfusion and result in fetal acidosis and neurological injury. Several techniques have been proposed to prevent hypotension.

The recommended spinal block height to ensure patient comfort for Cesarean delivery is T4-6. Clinically, it is desirable that the spread of local anesthetic through the cerebrospinal fluid (CSF) achieves a sensory level no higher than the T4 dermatome to avoid extensive sympathetic block. It is also important that the spinal block level be no lower than T6 to avoid patient discomfort during peritoneal manipulation and uterine exteriorization. The effect of injection speed on spread of spinal anesthesia is controversial. Several studies have demonstrated more extensive spread with faster injection while others report either greater spread with slower injection, or no difference. Slow injection of hyperbaric bupivacaine 10 mg over 60 and 120 sec has been shown to reduce the incidence and severity of hypotension during Cesarean delivery under spinal anesthesia.

详细描述

Patients admitted to undergo elective c-section under spinal anesthesia will be randomized using the sealed envelope technique to Group I who will receive intrathecal injection in a slow speed 1ml in 15 sec and group II who will receive 1ml in 5 sec.

The baseline pulse rate, blood pressure, respiratory rate, and oxygen saturation will be recorded intraoperatively. The presence of preoperative hypotension, nausea and vomiting, and level of block at 5 and 10 mins post intrathecal injection will be assessed .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
17 Years 至 45 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with American Society of Anesthesiology physical status 1 and 2
  • and scheduled for elective c-section surgery under spinal anesthesia

排除标准

  • Patients with cardiac and psychological problems
  • Patients who take sedatives or narcotics

研究组 & 干预措施

Low speed

Experimental

Patients will receive intrathecal injection of the anesthetic mixture in a slow speed (1ml in 15 seconds)

干预措施: Low speed (Other)

High speed

Active Comparator

Patients will receive intrathecal injection of the anesthetic mixture in a high speed (1ml in 5 seconds)

干预措施: High speed (Other)

结局指标

主要结局

Incidence of hypotension

时间窗: within one hour

demonstrate the effect of the injection speed (high and low) of the anesthesia mixture intrathecally on the incidence of hypotension measured through mean arterial pressure

次要结局

  • block level(5 and 10 minutes after performing the injection)
  • Number of participants experiencing nausea and vomiting(within one hour)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zoher Naja

Chairperson of Anesthesia and Pain Management Department

Makassed General Hospital

研究点 (1)

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