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临床试验/NCT04010318
NCT04010318已完成不适用

The Sensitivity of Goal Plethysmography Variability Index (PVI) Directed Pre-anesthesia Intravenous Fluid Infusion in the Prevention of Spinal Anesthesia Induced Hypotension in Elective Caesarian Section: Prospective Observational Study

Tanta University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
The incidence of post-spinal anesthesia hypotension

研究概览

简要总结

  • Full term pregnant female patients presented for elective C.S for single viable fetus will be included in this study.
  • Before anesthesia, the patient will be attached to a monitor of: ECG , heart rate, non invasive blood pressure, pulse taximeter applied on the index finger of the limb not attached to the blood pressure cuff, pulse oximetry and plethysmographic variability index (PVI) and perfusion index (PI) will be taken by (Massimo radical 7, Massimo corp. USA). Measures will be recorded every 5 minutes preoperative.
  • Patients with PVI <15 will be excluded from the study.
  • Patients with PVI > 15 are started on intravenous infusion of warm ringer lactate solution via suitable pore intravenous cannula to reach target of PVI <15 or a total 1 liter of ringer lactate.
  • The patients in which the PVI is corrected by fluid to level below 15 will be Group (C) or corrected group. Patients in which intravenous fluid administration did not result any change in PVI or changed but still higher than 15 will be Group (NC) or non corrected group.

After preoperative preparation patient is shifted to operating theater, with all monitors applied. She will receive spinal block at lumbar 3-4 space with hyperbaric bupivacaine 8 mg plus 25 mic fentanyl. After giving anesthesia and positioning for surgery with a left lateral tilt of 15 degrees,

详细描述

  • This prospective observational study will be carried out on all pregnant women who will undergo elective cesarean section in obstetric department in Tanta university hospitals under spinal anesthesia over four month duration that starts immediately after obtaining ethical committee approval, an informed written consent will be included with the consent for spinal anesthesia for cesarean section, all patients data will be confidential and will be used for the current study only.
  • Inclusion criteria:

Pregnant women which are listed to undergo elective caeserian section for single viable baby under spinal anesthesia.

  • Exclusion criteria:

  • Patients with pregnancy less than 36 weeks or more than 40 weeks

  • Patients with hypertension , pre-eclampsia , eclampsia.

  • Patients with diabetes

  • Patients with cardiovascular disease and /or arrhythmia.

  • Patients with placenta previa, accreta, percreta.

  • Obese patients with BMI >36

  • Polyhydramnious patients

  • On arrival of patients to pre-anaesthesia preparation room, we will allow patients to rest in supine position with 15 degree left tilt by pillow wedge under right hip, after allowing patient to rest for five minutes, measures are recorded: ECG , heart rate, non invasive blood pressure, pulse oximeter applied on the index finger of the limb not attached to the blood pressure cuff, pulse oximetry and Plethysmography variability index (PVI) and perfusion index (PI) will be taken by (Massimo radical 7, Massimo corp. USA). Measures will be recorded every 5 minutes preoperative. Patients with PVI <15 are excluded from the study.

Patients with PVI > 15 are started on intravenous infusion of warm ringer lactate solution via suitable pore intravenous cannula to reach target of PVI <15 or a total 1 liter of ringer lactate.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
21 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women which are listed to undergo elective caeserian section for single viable baby under spinal anesthesia.

排除标准

  • Patients with pregnancy less than 36 weeks or more than 40 weeks, Patients with hypertension , pre-eclampsia , eclampsia, Patients with diabetes, Patients with cardiovascular disease and /or arrhythmia, Patients with placenta previa , accreta, percreta, Obese patients with BMI >36, or Polyhydramnious patients.

结局指标

主要结局

The incidence of post-spinal anesthesia hypotension

时间窗: Through out the whole intraoperative period

The decrease in the mean arterial pressure below 65 mmHg or below 80% of the baseline value.

次要结局

  • The consumption of vasopressors(Through out the whole intraoperative period)

研究者

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

Sameh Abdelkhalik Ahmed Ismaiel

Dr

Tanta University

研究点 (2)

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