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临床试验/NCT05685212
NCT05685212已完成不适用

Prediction of Hypotension After Spianl Anesthesia During Cesarean Delivery: Utility of Positional Change of Hymodynamic Parameters

Mongi Slim Hospital1 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2023年4月1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
121
试验地点
1
主要终点
Incidence of hypotension

研究概览

简要总结

This was a prospective observational study between January 2022 and June 2022. The investigators included parturients aged 18 to 45 years, consenting, classified ASA II and III, scheduled for elective or emergency cesarean section (Lucas III-IV). Baseline hemodynamic parameters were measured in 3 different positions: sitting, supine, and left lateral tilt 15°. The investigators defined Δ1 as the change from the sitting position to the supine position ad Δ2 as the change from the left lateral tilt 15° position to the supine position. Our primary endpoint was the incidence of hypotension defined as a decrease of more than 20% from baseline values. The investigators performed univariate and then multivariate analysis.

详细描述

The investigators conducted a monocentric prospective observational study between January 2022 and June 2022, in the maternity unit of Mongi Slim University Hospital in Tunisia. The investigators aimed to have a population that is representative of all parturients scheduled for cesarean section, thereby they included American Society of Anesthesiologists physical status I and II parturients aged 18 to 45 at term and scheduled for either elective cesarean section or emergency cesarean section (Lucas III-IV).

The investigators chose hypotension as the primary endpoint, defined as a decrease in SAP of more than 20% of the baseline values. Secondary endpoints included total dose of ephedrine, incidence of symptomatic hypotension defined as hypotension plus nausea and/or vomiting and/or dizziness, time to onset of hypotension, duration of hypotension, and the use of rescue bolus of norepinephrine.

The investigators tried to standardize the anesthetic management. Parturients were monitored with a three-lead electrocardiogram, non-invasive arterial pressure, pulse oximetry, and capnography through a facial mask. Baseline maternal hemodynamic parameters were measured 3 times at 1-minute interval in three different positions: consecutively sitting position, supine position, and left lateral tilt 15° position. Spinal anesthesia was performed in the sitting position in the L3-L4 or L4-L5 vertebral interspace. Patients received doses of local anesthetic weighted to their height. Patients were co-loaded with an infusion of normal saline using a pressurized bad. Hypotension was treated with IV bolus of ephedrine in increments of 6 mg. If hypotension persisted or reoccurred after the patient had already received 60 mg of ephedrine, The investigators resorted to rescue bolus of norepinephrine in increments of 5 µg. After child delivery, patients received a standard dose of 10 IU of oxytocin, additional doses were added if the obstetrician requested it.

The investigators collected data regarding demographic characteristics, obstetric characteristic, anesthetic management, and details about the hypotensive event.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • American society of anesthesiologists' (ASA) physical status of II-III.
  • Full-term pregnancy.
  • Elective cesarean section.
  • Emergency cesarean section (Lucas III-IV).

排除标准

  • Emergency cesarean section (Lucas I-II).
  • Cesarean section under epidural anesthesia.
  • Patients with abnormal placentation.
  • Patients with contraindication for spinal anesthesia.
  • Patients with personal medical history of cardiac arrythmias or valvular heart disease.
  • Patients on beta-blockers.
  • Failed spinal anesthesia.
  • Conversion to general anesthesia.
  • Postpartum hemorrhage.

结局指标

主要结局

Incidence of hypotension

时间窗: 30 minutes after spinal anesthesia

a decrease in systolic arterial pressure more than 20% of the baseline (sitting position)

次要结局

  • Dose of ephedrine.(30 minutes after spinal anesthesia)

研究者

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

Mhamed Sami Mebazaa

Professor

Mongi Slim Hospital

研究点 (1)

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