跳至主要内容
临床试验/NCT06998537
NCT06998537尚未招募不适用

The Effect of Spinal Anaesthesia on Haemodynamic Parameters in Patients Receiving Alpha Blockers

Izmir City Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年8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
80
试验地点
1
主要终点
Preop,15 minute,30minute mean arteriyal pressure

研究概览

简要总结

There is frequent use of alpha blockers in elderly patients with urological disorders. Various side effects are encountered due to the use of alpha blockers in the elderly age group. Especially hypotension is one of the common side effects. In addition, urological surgery is frequently performed in this age group. Spinal anesthesia is the most preferred anesthesia method in urological surgery. Spinal anesthesia may cause significant vasodilatation and thus hemodynamic changes such as hypotension by causing sympathetic nerve blockade. It is predicted that spinal anesthesia may increase these effects especially in individuals using α-1 adrenergic blockers. In the literature, serious hypotension has been encountered in individuals using alpha blockers under general anesthesia. The aim of this study was to compare the intraoperative hemodynamic changes in patients undergoing elective urologic surgery under spinal anesthesia between α-1 adrenergic blocker users (Group 1) and non-users(Group 2). Patients were divided into two groups according to drug use: Group 1: α-1 adrenergic blocker users (alfuzosin, doxazosin, terazosin,silodosin, tamsulosin), Group 2: No α-1 adrenergic blockers.

详细描述

Although α-1 adrenergic receptor blockers were initially developed for the treatment of hypertension, they have been widely used in the treatment of benign prostatic hyperplasia (BPH) over the last decade. α-1 adrenergic blockers are frequently used in the treatment of conditions such as benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS), which are common in older age groups. α-1 adrenergic receptor blockers contribute to symptom relief by relaxing the smooth muscles of the prostate and bladder neck through inhibition of the sympathetic nervous system . However, blockers that are not receptor selective and cause vascular effects cause an increased risk of hypotension and dizziness when used at therapeutic levels. The hemodynamic effects of α-1 adrenergic blockers are a potential concern, especially in elderly patients. Physiologic changes with age, such as decreased cardiac output, impaired baroreceptor sensitivity, decreased plasma renin levels and renal function, make this patient group more vulnerable to complications related to vasodilation induced by α-blockers. This group of patients also frequently undergoes urological surgery and these procedures are usually performed under spinal anesthesia. Spinal anesthesia may cause significant vasodilatation and thus hemodynamic changes such as hypotension by causing sympathetic nerve blockade. It is predicted that these effects of spinal anesthesia may be increased especially in individuals using α-1 adrenergic blockers. However, there is insufficient data in the literature on the effect of α-1 adrenergic blocker use on intraoperative hemodynamic changes in patients undergoing spinal anesthesia. Existing publications have mostly focused on cases of severe hypotension after general anesthesia. The aim of this study was to compare the intraoperative hemodynamic changes in patients undergoing elective urologic surgery under spinal anesthesia between α-1 adrenergic blocker users(Group 1) and non-users(Group 2).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with American Society of Anesthesiologists (ASA) physical status classification I,II or III over 18 years of age scheduled for elective urologic surgery under spinal anesthesia

排除标准

  • Patients not undergoing spinal anesthesia, non-alpha-blocker vasoactive drug users, patients with cardiac disease, medical/surgical history of brain or spinal cord, neurological or psychiatric disease

结局指标

主要结局

Preop,15 minute,30minute mean arteriyal pressure

时间窗: During procedure (From the beginning to the end of anesthesia)

Hypotension MBP \< 50 mmHg

次要结局

  • Preoperative, 15th and 30th minute heart rate(During procedure (From the beginning to the end of anesthesia))

研究者

发起方
Izmir City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Tuba Kuvvet Yoldaş

MD,Specialist

Izmir City Hospital

研究点 (1)

Loading locations...

相似试验