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临床试验/CTRI/2024/12/077977
CTRI/2024/12/077977尚未招募不适用

Phenylephrine boluses vs continuous infusion for preventing post spinal hypotension in low risk parturients undergoing elective caesarean section- A prospective observational study

Department of Anaesthesiology1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年12月30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
90
试验地点
1
主要终点
Incidence of hypotension during procedure

研究概览

简要总结

Hypotension remains the most common complication following spinal anaesthesia, potentially leading to adverse maternal and foetal outcomes. Intravenous vasopressors such as Phenylephrine, Ephedrine and Mephenteramine are widely used to manage this. Prospective observational study at Al- Azhar Medical College and Superspecialty Hospital with a duration of 6 months. Study population include low risk parturients undergoing elective caesarean section. Sample size is 90.The study will be started after getting permission. Informed consent will be obtained from the patient prior to study participation. Patients will be divided into two groups A and B. Group A includes patients receiving Phenylephrine continous infusion. Group B includes patients receiving Phenylephrine intermittent boluses.All patients in our study undergoing caesarean section will be receiving spinal anaesthesia in sitting position using 25G whitacre/ Quincke needle. The drug administered intrathecally will be 0.5% Bupivacaine Heavy 2.2 mls. A sensory level of T5 will be ensured before the start of surgery. Group A will receive iv continuous infusion of phenylephrine at 0.5-0.6mcg/kg/min started immediately after spinal anesthesia and continued until Pitocin bolus is given after baby delivery. BP will be measured every minute.iv bolus of 50 mcgphenylephrine will be given if bp drops to less than 80 percentage of base line values. If HR falls below 50/min or if the SBP goes above 20% of baseline, the infusion of Phenylephrine will be held until it recovers. Patients in Group B will receive intermittent boluses of Phenylephrine 25 mcg iv every 3rd minute after spinal anaesthesia and this will be continued until Pitocin bolus is given after baby delivery and BP will be recorded every minute. iv bolus of 50 mcg phenylephrine will be givenwhen bp falls less than 80% baseline. If HR falls below 50/min or if the SBP goes above 20% of baseline, the next dose of intermittent bolus will be held until it recovers. After 1 minute of spinal anesthesia, heart rate, SBP and DBP are recorded every minute until baby delivery. After baby delivery, apgar score will be measured at 1 minute and 5 minutes.Primary outcome isIncidence of hypotension during the procedure (BP drops to less than 80 percentage of base line).Secondary outcomes is maternal and fetal complications , adverse effects of phenylephrine, maternal satisfaction and recovery time

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • elective cesarean section ASA 2.

排除标准

  • Cesarean section under general anesthesia ASA grade 3 and above hypotension associated with bradycardia emergency cesarean section.

结局指标

主要结局

Incidence of hypotension during procedure

时间窗: 30 seconds | 1 minute | 1 minute 30 seconds | 2 minutes

次要结局

  • maternal and fetal complications(adverse effects of phenylephrine)

研究者

发起方
Department of Anaesthesiology
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Jose Paul

Kerala University of Health Sciences

研究点 (1)

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