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临床试验/CTRI/2024/02/062962
CTRI/2024/02/062962尚未招募不适用

An observational comparative study to assess the hemodynamic changes between preeclampsia patient versus healthy parturients after spinal anaesthesia during elective cesarean section

Department of anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年2月25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
1. Change in intraoperative hemodynamic variables in terms of mean SBP , mean DBP , mean MAP (mmHg ) and mean HR (min)

研究概览

简要总结

Spinal anaesthesia is generally preferred anaesthetic technique in preeclampsia patients as there are lower incidence of spinal induced hypotension and the vasopressor requirement in them . A total of 100 parturients fulfilling the inclusion criteria ( 50 preeclamptic and 50 healthy ) will be enrolled in the study after providing informed written consent . In operation theatre baseline hemodynamic variable ( systolic blood pressure ,diastolic blood pressure , mean arterial pressure , HR and SPO2 ) will be recorded . A 18G cannula will be secured and preoperative fluid equal to 10ml /kg of Ringer’s lactate will be administered to each patient over the course of 15- 20 min. Under aseptic precaution Spinal anaesthesia will be performed with 10mg hyperbaric 0.5% bupivacaine in two groups in sitting position in the L3 - L4 vertebral interspace , Each patient will be placed in supine position with a left lateral tilt of 15- 20 degree . The height of sensory block will be assessed using a pin prick test. After achieving an adequate sensory block (T6 level ) the surgery will be started . HR and BP will be recorded before performing spinal anaesthesia , at 2 min interval for 15 min after the block and then every 5 min until the end of surgery . Patient will also be assessed for hemodynamic changes , requirement of injection ephedrine , intraoperative fluid and complication if any .

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Patient providing consent Patient belonging to ASA II and III Patient with preeclampsia BP more than 140/90 mmHg after 20 weeks of gestation and proteinuria more than plus 2.

排除标准

  • Non cooperative patient Patient should not be part of any other study Patient with contraindication to neuraxial anaesthesia patient with cardiac diisease , chronic hypertension and gestational hypertension Patient with renal disease , coagulopathy platelet count less than 80000 and high spinal Patient with active labor , eclampsia , abruption placenta , placenta previa and twin pregnancy.

结局指标

主要结局

1. Change in intraoperative hemodynamic variables in terms of mean SBP , mean DBP , mean MAP (mmHg ) and mean HR (min)

时间窗: 1. 00 min | 2. 2min | 3. 4min | 4. 6min | 6. 8min | 7. 10min | 8. 12min | 9. 14min | 10. 20min | 11. 25min | 12. 30min | 13. 35min | 14. 40min | 15. 45min | 16. 50min | 17. 55min | 18. 60min

2. Difference in mean total dose of ephedrine required (mg)

时间窗: 1. 00 min | 2. 2min | 3. 4min | 4. 6min | 6. 8min | 7. 10min | 8. 12min | 9. 14min | 10. 20min | 11. 25min | 12. 30min | 13. 35min | 14. 40min | 15. 45min | 16. 50min | 17. 55min | 18. 60min

3. Difference in mean total amount of intraoperative fluid required (ml)

时间窗: 1. 00 min | 2. 2min | 3. 4min | 4. 6min | 6. 8min | 7. 10min | 8. 12min | 9. 14min | 10. 20min | 11. 25min | 12. 30min | 13. 35min | 14. 40min | 15. 45min | 16. 50min | 17. 55min | 18. 60min

次要结局

未报告次要终点

研究者

发起方
Department of anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Harpreet Kaur

Sawai Man Singh Medical College and Attached Hospital

研究点 (1)

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