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临床试验/NCT05285800
NCT05285800已完成3 期

To Determine the Effectiveness of Saddle Block vs Spinal Anesthesia in TURP

Hamdard University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年9月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Haemodynamic status

研究概览

简要总结

To determine the effectiveness of saddle block vs spinal anesthesia in TURP.

详细描述

This study is being conducted to determine the effectiveness of saddle block vs spinal anesthesia in terms of haemodynamic stability and Vasopressor usage.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patient with absolute contraindication of general anaesthsia
  • Patients who gave consent and willing to be included in study
  • Patient's having age range between 45 years to 65years
  • Well controlled diabetes and hypertension
  • ASA grade I & II

排除标准

  • Patients with absolute contraindications of regional anesthesia,
  • Deformity of vertebral column,
  • Thyroid disorder,
  • Psychiatric illness,
  • Neurological diseases,
  • Alcohol addiction,
  • Ischemic heart diseases and
  • Not willing to participate

研究组 & 干预措施

Saddle group

Experimental

After administration of 12mg of 0.5 % Hyperbaric Bupivacaine intrathecally, Patient is advised to remain in Sitting position for the next 5minutes and then take supine position

干预措施: 0.5% Hyperbaric Bupivacaine (Drug)

Spinal group

Active Comparator

After administration of 12mg of 0.5% Hyperbaric Bupivacaine intrathecally, Patient is advised to take Supine position immediately.

干预措施: 0.5% Hyperbaric Bupivacaine (Drug)

结局指标

主要结局

Haemodynamic status

时间窗: Haemodynamic status checked from 0minutes ( as the patient takes supine position) for every 5minutes interval till the end of surgery.

Haemodynamic status includes pulse rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure and oxygen saturation. Pulse rate ranges between 60-100 beats/ minute. Pulse above 100 is called tachycardia and below 60 is called bradycardia Systolic blood pressure more than 140mmhg is called systolic hypertension and lower than 90mmhg is known as systolic hypotension. Diastolic blood pressure more than 90mmhg is called diastolic hypertension and lower than 60mmhg is called diastolic hypotension. Mean arterial pressure ranges between 70-110. More than 110 labeled as hypertension and below 70 means hypotension. Spo2 level below 94% is labeled as hypoxia.

Vasopressor usage

时间窗: Blood pressure is taken from 0minute (as the patient takes supine position) at every ⁵minutes interval till the end of surgery

The main side effect of intrathecal 0.5 % hyperbaric Bupivacaine is hypotension. That is countered by using vasopressor drug e.g inj. Ephedrine. Critically low blood pressure e.g systolic bp below 90mmhg, diastole c blood pressure below 60mmh and MAP below 60 is an indication for vasopressor introduction.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Muhammad Wajid Iqbal

Resident medical officer, Anesthesiology

Hamdard University

研究点 (1)

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