跳至主要内容
临床试验/NCT03440502
NCT03440502Unknown不适用

Effect of Diabetes Mellitus on Spinal Block Criteria During Cesarean Section

Assiut University0 个研究点目标入组 300 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
主要终点
the incidence of complete failure of spinal block.

研究概览

简要总结

The current study aimed at studying the effect of DM during pregnancy on the spinal block criteria during C.S.

The primary end point of the trial is the incidence of complete failure of spinal block.

Secondary endpoint is to determine the effect of DM on the other spinal block criteria as onset and duration of block, level of spinal block, rate of regression, hemodynamic changes, doses of inotropes and incidence of complications

详细描述

Regional anaesthetic techniques are now the most frequently used type of anaesthetic used for caesarean deliveries. They have a better safety profile than general anaesthesia in the pregnant woman. The choice of whether to use a spinal, epidural or combined spinal-epidural technique will depend on patient and surgical factors.

Although spinal (subarachnoid or intrathecal) anaesthesia is generally regarded as one of the most reliable types of regional block methods, the possibility of failure has long been recognized.

Most experienced practitioners would consider the incidence of failure with spinal anaesthesia to be extremely low, perhaps less than 1%. However, a figure as high as 17% has been quoted from an American teaching hospital, yet most of the failures were judged to be 'avoidable Spinal anaesthesia (SA) is a frequently used anaesthetic technique, and success rates and patient satisfaction are generally high. However, there are numerous reports of failed SA (FSA), and published failure rates in large series of SA range from 0.46% to 17%. The reasons most commonly provided to explain failure are technical problems, errors of judgement with respect to pharmacological factors, such as inadequate dose of local anaesthetic (LA), and inadequate positioning of the patient. . Proposed mechanisms for inadequate block despite correct dosing and injection technique are maldistribution , variability in the anatomy of the lumbar subarachnoid space, inadvertent subdural or epidural injection, and resistance to the effects of LA.

Successful spinal anaesthesia requires the deposition of the correct dose of the correct drug in the CSF that is in free continuity with the spinal cord and cauda equina, and that there are no barriers, either physiological, biochemical or mechanical, to prevent the normal anticipated action of the drug in the spinal cord. Gestational diabetes mellitus (GDM) refers to any degree of glucose intolerance with onset or first recognition during pregnancy. It occurs in 2-9% of all pregnancies and accounts for 90% of cases of diabetes mellitus complicating pregnancy. A1C is routinely measured approximately every 3 months in individuals with diabetes to assess the mean glucose concentration. The erythrocyte life span is ∼120 days. Thus, the 3-month interval between tests of A1C reflects the mean blood glucose over the preceding weeks to months. Hence, the rate of change of A1C in pregnancy reflects the glycemic control over the past few weeks Hoppe et al. declared diabetes mellitus (DM)as a possible cause of SA failure in a case series consisting four obstetric patients.

two possible factors may be important for quality and level of SA inpatients with DM. First is neuropathy and second is possible changes in composition of CSF such as density or volume secondary to hyperglicemia in blood and CSF .So the investigators hypothesized that DM could affect the success of SA

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Inclusion criteria for control group.
  • Parturients aged 18 or older (American Society of Anesthesiologist physical status II-III parturients ASA II-III) undergoing cesarean delivery under spinal anaesthesia, singleton pregnancy, full term, elective.
  • Inclusion criteria for study group.
  • The same as control group but with DM or gestational diabetes.

排除标准

  • Parturients taller than 180 cm or shorter than 150 cm.
  • Body mass index > 45 kg/m
  • Known anatomical anomaly such as scolyosis or kyphosis.
  • Refusal of spinal anesthesia.
  • Contraindications to spinal anaesthesia (allergy to local anaesthetic or a bleeding diathesis or infection at the site of injection).

结局指标

主要结局

the incidence of complete failure of spinal block.

时间窗: two years

effect of DM during pregnancy on the spinal block criteria during C.S the incidence of complete failure of spinal block.

次要结局

  • determine the effect of DM on the other spinal block criteria(two years)

研究者

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

Alyaa Alaa Aldin Abd Manaf

doctor

Assiut University

相似试验

Effect of Diabetes Mellitus on Spinal Block Criteria... | 临床试验