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临床试验/CTRI/2025/03/082139
CTRI/2025/03/082139尚未招募不适用

Clinical utility of preoperative bilateral carotid artery corrected flow time (FTc) and carotid artery pulsatility index(PI) for predicting hypotension after spinal anesthesia in parturient undergoing elective caesarean section in tertiary care hospital

Dr Sugandha1 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2025年4月9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
310
试验地点
1
主要终点
Prediction of post spinal hypotension in pregnant women undergoing cesarean by measuring corrected flow time and pulsatility index of carotid artery

研究概览

简要总结

The parturient scheduled for an elective cesarean section under spinal anesthesia will be recruited after obtaining informed and written consent one day prior to surgery. After being transferred to the operating room, standard ASA monitors will be attached to the parturient. Baseline values of heart rate, systolic blood pressure, diastolic blood pressure, and mean arterial pressure will be recorded with the table in a left lateral tilt at 15-20 degrees. A high-frequency linear ultrasound probe will be placed over the common carotid artery, approximately 2 cm proximal to the carotid bifurcation, to obtain Doppler waveforms. These measurements will be taken with the table in a left lateral tilt at 15-20 degrees. The data obtained from each side will be used to calculate the corrected flow time interval (FTc) and pulsatility index (PI).Following the ultrasound assessments, the parturient will be positioned for spinal anesthesia, and 0.5% hyperbaric bupivacaine (1.8-2 ml) will be administered. The parturient will then be turned supine with a wedge placed under the right hip. The level of sensory block will be confirmed by the response to cold touch. Systolic blood pressure will be measured at one-minute intervals after spinal anesthesia until the delivery of the baby. Hypotension will be defined as a decrease in systolic blood pressure to less than 100 mmHg or a fall of more than 80% from baseline. Any hypotension will be treated with intravenous vasopressors, and the details of the treatment will be recorded. The obtained data will be analyzed to identify any correlation with post-spinal hypotension.

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

  • All ASA Physical Status II Parturients with singleton pregnancy undergoing elective caesarean section under spinal anesthesia.

排除标准

  • 1.Parturient not fit for Spinal Anesthesia 2.Parturient who has cardiovascular conditions like hypertension, arrhythmias, valvular heart disease, or other significant cardiac conditions 3.Parturient with pregnancy-induced hypertension disorder.
  • 4.Parturient on medications that affect cardiovascular function (e.g. beta-blockers, vasodilators, prophylactic vasopressors) 5.Parturient with Carotid stenosis.

结局指标

主要结局

Prediction of post spinal hypotension in pregnant women undergoing cesarean by measuring corrected flow time and pulsatility index of carotid artery

时间窗: Carotid artery ultrasound measurements will be done preoperatively and maternal hemodynamic parameters will be measured from baseline to delivery of the baby in every 1 minute interval

次要结局

  • To identify the relationship between preoperative carotid corrected flow time (FTc) & pulsatility index(PI) with post spinal hypotension index among parturients undergoing elective lower segment caesarean section in tertiary care hospital(Carotid artery ultrasound measurements will be done preoperatively & maternal hemodynamic parameters will be measured from baseline to delivery of the baby in every 1 minute interval)

研究者

发起方
Dr Sugandha
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sugandha

Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER)

研究点 (1)

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