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临床试验/CTRI/2024/06/068502
CTRI/2024/06/068502尚未招募不适用

Comparison of the Haemodynamic Changes in Normotensive and Preeclamptic Pregnant Woman Posted for Cesarean Section Under Subarachnoid Block- Prospective Observational Study

Vijayanagar institute of medical sciences1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2024年6月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
138
试验地点
1
主要终点
Incidence of hypotension

研究概览

简要总结

This study will be conducted on  pregnant woman of ASA physical II (Normotensive) or III Preeclamptic(hypertension to the extent of 140/90mmhg or more in two occasions 6hours apart with proteinuria(more than 300 mg/24hours) after 20th week of pregnancy in previously normotensive or non-protienuric patients), , carrying a live, mature, healthy, single fetus scheduled for cesarean section under SAB. Patients will be counselled during preoperative examination  and will be recruited for this study after obtaining informed consent from each of the patient in their own language. Patients with chronic hypertension, diabetes mellitus, known cardiac disease, renal disease, and coagulopathy; with contraindication to subarachnoid block, known sensitivity to the study drugs and patients refusing to either regional anesthesia or the study technique will also be excluded from the study. Any patients showing signs or alarming symptoms for eclampsia will be excluded from the study and managed with IV MgSO4 wherever indicated. All antihypertensives will be continued till the day of surgery. After receiving the patient in the operating room, documents will be checked, a brief clinical examination will be done and standard ASA monitors will be attached including ECG, pulse oximetry and temperature probe.  Baseline heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP) will be recorded. After establishing IV access with an 18G cannula 20 ml/kg lactated ringer solution (RL) will be administered for prehydration. After proper aseptic precaution spinal subarachnoid block (SAB) will be performed by an anesthesiologist, at L3-L4 intervertebral space through a midline approach. Surgery will be allowed after adequate sensory and motor block confirmed (T6 level). Immediately after delivery of head of the baby oxytocin 5 IU will be administered over 1 minute followed by infusion at the rate of 5 IU/H for 2 hours. Intraoperative blood loss of the mother will be assessed from the drainage in suction bottles and checking the swabs and mops used, clots and appropriate replacement done. HR, SBP, DBP and MAP will be recorded every 2minutes for first 15minutes and every 5mintes after that throughout the procedure.  The data will be labeled as group N for normotensives and group P for pre-eclamptics and will be analyzed.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Pregnant patients belonging to ASA 2 and 3 status, Patients scheduled for LSCS with normotensives or preeclampsia.

排除标准

  • Patient refusal for spinal anaesthesia, history of allergy to drugs, any contraindications for spinal anaesthesia, pre-diagnosed eclampsia, HELLP syndrome, severe fetal distress, cord prolapse, twin pregnancy, antepartum hemorrhage, morbid obesity, pre-diagnosed chronic hypertension, diabetes mellitus, known cardiac disease, renal disease and coagulopathy.

结局指标

主要结局

Incidence of hypotension

时间窗: After spinal anaesthesia every 2 minutes till initial 20 minutes there after every 5 minutes till end of the procedure.

次要结局

  • Grades of hypotension, Use of vasopressors, Use of oxytocis, Intravenous fluid requirement,Amount of blood loss(After spinal anaesthesia every 2 minutes till initial 20 minutes there after every 5 minutes till end of the procedure.)

研究者

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

Dr Arun

Vijayanagar institute of medical sciences, Ballari

研究点 (1)

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