跳至主要内容
临床试验/NCT04037774
NCT04037774Unknown4 期

Comparision of Different Doses of Dexmedetomidine With Low Dose Bupivacaine in Selective Spinal Anesthesia for Transurethral Resection of Prostate in Elderly Males.

Services Institute of Medical Sciences, Pakistan1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年9月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
75
试验地点
1
主要终点
duration of post-operative analgesia

研究概览

简要总结

The charactereistics of a spinal block varies with the dose of local anaesthetic and the adjuvant used. Literature review did not show comparison of different doses of dexmedetomidine with low-dose bupivacaine in saddle block. The rationale of this study is to determine an optimum dose of dexmedetomidine which in combination with low dose bupivacaine would provide satisfactory block with hemodynamic stability. This would be beneficial for patients scheduled for turp, as these pts are mostly elderly with various comorbidities.

详细描述

SYNOPSIS:

Comparison of different doses of intra-thecal dexmedetomidine as an additive to low-dose bupivacaine(5mg) in selective spinal anesthesia for transurethral resection of prostate in elderly patients.

Introduction:

Most patients scheduled for Transurethral Resection of the Prostate Gland are elderly and usually present with cardiovascular, endocrine, renal, cerebral or respiratory diseases thereby increasing their risk for surgery and anaesthesia. Spinal anesthesia is the technique of choice in transurethral resection of prostate . The major problem of spinal technique is risk of hypotension. In spinal anesthesia due to sympathetic blockade, there is vasodilatation leading to diminished venous return which is the main contributory factor for hypotension. 1 Selective spinal anesthesia , commonly known as saddle block, is defined as "the practice of employing minimal doses of intrathecal agents so that only the nerve roots supplying a specific area and only the modality that require to be anesthetized are affected." Thus, Selective spinal anesthesia is more appropriate in elderly patients3 Saddle block paralyzed pelvic muscles and sacral nerve roots. As lower level of block is achieved, hemodynamic derangement is less and fluid requirement is also less. So there is minimum chance of circulatory overload1 but may provide insufficient surgical anaesthesia.5and also may not achieve an extended duration of postoperative analgesia.2 Dexmedetomidine is a highly selective alpha2 adrenoceptor (α2-AR) agonist recently introduced to anaesthesia practice. It produces dose-dependent sedation, anxiolysis and analgesia (involving spinal and supraspinal sites) without respiratory depression7 intrathecal Dex has been used as an adjuvant to different local anesthetics in humans with various doses ranging from 2.5 to 15 micrograms [2,3,9-15] resulting in improving the quality of sensory and motor blockade and increasing their duration and decreasing the dose of local anesthetic used intrathecal Dex has been used as an adjuvant to different local anesthetics in humans with various doses ranging from 2.5 to 15 micrograms [2,3,9-15] resulting in improving the quality of sensory and motor blockade and increasing their duration and decreasing the dose of local anesthetic used intrathecal Dex has been used as an adjuvant to different local anesthetics in humans with various doses ranging from 2.5 to 15 micrograms, resulting in improving the quality of sensory and motor blockade and increasing their duration and decreasing the dose of local anesthetic used.4

RATIONALE:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

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

入选标准

  • Male gender Age between 50 and 70 years old Patients' physical status by the American Society of Anesthesiologist (ASA): ASA class I, II and III

排除标准

  • Contraindications of spinal anesthesia, Patients who were taking α2-adrenergic agonist or antagonist therapy, Patients who were having labile hypertension, uncontrolled cardiac disease, heart block/dysrhythmia, autoimmune disorders, Communication difficulties, e.g. mental retardation or deafness Allergy to the drug or local anesthetics.

研究组 & 干预措施

dex 5microgram

Active Comparator

this group of patients is given total 2ml solution intrathecally, 1ml of 5mg local anesthetic i.e 0.5% hyperbaric bupivacaine and 1ml of 5micrograms of dexmedetomidine.

干预措施: Dexmedetomidine (Drug)

dex 10microgram

Active Comparator

this group of patients is given total 2ml solution intrathecally, 1ml of 5mg local anesthetic i.e 0.5% hyperbaric bupivacaine and 1ml of 10micrograms of dexmedetomidine.

干预措施: Dexmedetomidine (Drug)

placebo

Placebo Comparator

this group of patients is given total 2ml solution intrathecally, 1ml of 5mg local anesthetic i.e 0.5% hyperbaric bupivacaine and 1ml of placebo.

干预措施: placebo (Other)

结局指标

主要结局

duration of post-operative analgesia

时间窗: upto 6months

duration the patient remains pain free from administration of drug.

次要结局

  • side effects(upto 6 months)
  • peak sensory level(upto 6 months)
  • 2 segment regression(upto 6 months)

研究者

发起方
Services Institute of Medical Sciences, Pakistan
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

dr. sana siddiq

professor of anesthesiology

Services Institute of Medical Sciences, Pakistan

研究点 (1)

Loading locations...

相似试验