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临床试验/NCT02619019
NCT02619019已完成2 期

Intrathecal Dexamethasone in Patients Undergoing Transuretheral Prostatectomy.

Assiut University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
90
试验地点
1
主要终点
Shivering

研究概览

简要总结

Dexamethasone, a high-potency, long-acting glucocorticoid, when added to bupivacaine, it extended the duration of analgesia. We aim to study the effectiveness of spinal dexamethasone in Transuretheral prostatectomy.

详细描述

Spinal anesthesia for endoscopic urology surgery like transurethral resection of the prostate is a well-established technique. Opioids are extensively used as an adjunct to local anesthetics in neuraxial blockade to enhance the duration of postoperative analgesia. However, worrisome adverse effects like pruritus, urinary retention, postoperative vomiting and respiratory depression limit its use. The aim of this study was to investigate the effectiveness of Intrathecal dexamethasone as adjunct to local anesthetics.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Age: 50-75 yr ASA class I,II, and III undergoing Transuretheral prostatectomy under spinal anesthesia

排除标准

  • Contraindications to spinal anesthesia, Allergy to the study medication, Thyroid disease, Parkinson's disease Patients receiving vasodilators or medications likely to alter thermoregulation.

研究组 & 干预措施

Dexamethasone group

Active Comparator

Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 8 mg of dexamethasone intrathecally

干预措施: Dexamethasone (Drug)

Pethidine group

Active Comparator

Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 0.2 mg/kg of pethidine intrathecally

干预措施: Pethidine (Drug)

Control group

Placebo Comparator

Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 2 ml normal saline intrathecally

干预措施: Normal saline (Drug)

结局指标

主要结局

Shivering

时间窗: 150 min after spinal anesthesia

by shivering score

次要结局

  • Heart rate(150 min after spinal anesthesia)
  • Core temperature(150 min after spinal anesthesia)
  • Mean arterial blood pressure(150 min after spinal anesthesia)

研究者

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

Seham Mohamed Moeen Ibrahim

lecturer

Assiut University

研究点 (1)

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