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临床试验/CTRI/2024/08/071767
CTRI/2024/08/071767尚未招募Phase 3 4

Comparison of prophylactic equipotent norepinephrine and phenylephrine infusion for the treatment of post spinal anaesthesia induced hypotension - a prospective double blinded randomized controlled clinical trial

未提供1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2024年8月12日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
入组人数
108
试验地点
1
主要终点
Incidence of spinal anaesthesia induced hypotension where mean arterial pressure is less than 80% of the baseline reading for 45 minutes and not related to blood loss

研究概览

简要总结

Hypotension following spinal anaesthesia is most commonly encountered event. Vasopressors are the most preferred drugs to treat and prevent hypotension due to spinal anaesthesia. Currently both norepinephrine and phenylephrine are the favored vasopressor to counteract spinal anaesthesia induced hypotension in obstetric population. There are not many studies comparing the effect of equipotent dose of norepinephrine and phenylephrine in treating spinal anaesthesia among elderly population. In this study we aim to compare the changes in heart rate and blood pressure following prophylactic intravenous infusions of norepinephrine or phenylephrine in elderly patients under elective surgery under spinal anaesthesia. We will recruit elderly patients above 50 years of age considering all the inclusion and exclusion criteria. In this randomized double blind study, we will obtain informed consent from the patient and after administration of spinal anaesthesia we start infusion of either norepinephrine or phenylephrine after one minute in our sample of patients and will monitor for incidence of hypotension, bradycardia, reactive hypertension and other adverse events for 45 minutes following the spinal anaesthesia procedure. Postoperatively we will monitor the patient in recovery room the next 24 hours for any adverse events. We will note the entire collected data onto study proforma and uploaded onto excel sheet. Statistical analysis will be done.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
50.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • (1) Elderly patients (more than 50 years) who are scheduled for surgery under spinal anaesthesia (2) Patients of American society of anaesthesiologists I,II,III.

排除标准

  • Contraindication of spinal anaesthesia.
  • History of allergy to any of the study drugs.
  • Patients with cardiac morbidities.
  • Hypertensive patients.
  • Patients with advanced comorbidity like hyperthyroidism and autonomic neuropathy.
  • Patients on heart rate regulating drugs.

结局指标

主要结局

Incidence of spinal anaesthesia induced hypotension where mean arterial pressure is less than 80% of the baseline reading for 45 minutes and not related to blood loss

时间窗: At baseline, each minute for the first 10 minutes, every 3rd minute for the next 35 minutes after induction of spinal anesthesia

次要结局

  • 1.Mean heart rate beats per minute(2.The proportion of patients having bradycardia with heart rate less than 50 beats per minute.)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Chatakondu Sneha

Sri Venkateswara Institute of Medical Sciences, Tirupati

研究点 (1)

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