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临床试验/CTRI/2025/08/093333
CTRI/2025/08/093333尚未招募不适用

Role of Echocardiography in predicting sub-arachnoid block induced hypotension in elective lower segment cesarean section patients: a prospective observational study.

IGMCRI1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年8月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Predict the hypotension following spinal anesthesia by using VTI change from supine to passive leg raise

研究概览

简要总结

Eligible participants, i.e., term pregnant women scheduled for elective cesarean section under spinal anesthesia, will be recruited consecutively after obtaining written informed consent. Patient will be shifted into the operating theatre and placed on the table with 45 degrees back elevation. Baseline demographic details and vital signs (heart rate and blood pressure) and will be recorded in the supine position.  Echocardiography will be performed and the parasternal long axis (PLAX), parasternal short axis (PSAX) and  apical 5-chamber (A5C) views identified. Echocardiography will  be performed by the same Consultant to avoid inter-observer bias. The echocardiographic parameters namely:  LVOT(Left ventricular outflow tract) VTI, LVEDA, LVOT Diameter are measured. The patient is then placed in the supine position with wedge ( using a standard wedge ensuring 15 degrees tilt measured using a goniometer) and the parameters are recorded after resting the patient in the position for 3 min. Then the back of the patient will be made supine (Passive leg raise (PLR)) and the echo parameters recorded  after 90 seconds. These values will be used to calculate VTI% and LVEDA%, which reflect hemodynamic changes with position. MAP and HR will be continuously recorded during the USG measurements. Following ultrasound recording, the patient will be given intravenous fluid bolus of 50 mL/Kg (Ringer’s lactate or Normal Saline). Spinal anesthesia will be administered using 2 cc of 0.5% Bupivacaine hyperbaric in the left lateral position, and the patient will be placed in the supine position with a 15° left lateral tilt. Mean arterial pressure (MAP) and heart rate will be monitored at 1-minute intervals until delivery or upto 10 min following spinal anesthesia administration. Hypotension will be defined as a >20% decrease in MAP from baseline. The occurrence of hypotension, use of vasopressors (e.g., phenylephrine), and any maternal adverse effects (such as nausea or dizziness) will be recorded. All findings will be entered in a structured case record form, and participants will be categorized into hypotension and normotension groups for subsequent analysis.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Term pregnancy, singleton, 37 weeks Normal blood pressure elective cesarean section spinal anesthesia able to give consent.

排除标准

  • Contraindications to spinal anesthesia, including: • Coagulopathy • Sepsis • Allergy to local anesthetics
  • Presence of significant medical comorbidities, such as: • Pre-eclampsia • Cardiac disease • Neurological disorders
  • Multiple gestation
  • Obstetric complications like placenta previa or abruptio placentae
  • Emergency cesarean section
  • Failure to achieve adequate spinal block up to T6 dermatome within 10 minutes
  • Inability to obtain usable ultrasound images.

结局指标

主要结局

Predict the hypotension following spinal anesthesia by using VTI change from supine to passive leg raise

时间窗: 15 min following delivery

次要结局

  • Individual predictive value of VTI% , LVEDA, MAP and HR(15 min following delivery)
  • To evaluate VTI change between supine and supine (with wedge)(15 min following delivery)
  • To evaluate maternal adverse effects(15 min following delivery)
  • To assess feasibility(Preoperative period)

研究者

发起方
IGMCRI
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Yuvasri

IGMCRI

研究点 (1)

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