The Effect of Intrathecal Versus Intravenous Dexmedetomidine on Postoperative Analgesia in Transurethral Resection of The Prostate
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Time to first analgesic request
研究概览
简要总结
This study was conducted to compare the effects of intrathecal versus intravenous dexmedetomidine administration in patients undergoing Transurethral resection of the prostate under spinal anesthesia.
详细描述
Multiple prostatic pathologies become evident in the elderly males. Of them, benign prostatic hyperplasia is one of the most prevalent issues in aging men and transurethral resection of the prostate (TURP) still represents the standard surgical treatment.
Most transurethral resection of the prostate (TURP) procedures are performed under spinal anesthesia. Spinal anesthesia has many advantages including, easy application, low cost, decreasing the risk of aspiration, decreasing intraoperative bleeding, eliminating the need for mechanical ventilation together with the decreased risk of intraoperative cardiac events or post-operative hypoxic episode.
The management of post-operative pain following spinal anesthesia using a short-acting anesthetic still constitutes a major problem for anesthesiologists and pain physicians. However, the duration and efficacy of spinal anesthesia could be improved by adjuvants.
Dexmedetomidine is an alpha 2 receptor agonist that have antinociceptive action for both visceral and somatic pain. At low doses, it has sedative and hypnotic effects without having a negative impact on respiration. Multiple studies have reported that intrathecal and intravenous administration of this drug could prolong the duration of spinal anesthesia and post-operative analgesia.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Cases aged between 50 and 70 years
- •Having class I or II according to the American society of anesthesiologists (ASA)
排除标准
- •Cases with heart block
- •Dysrhythmia
- •Contraindications for spinal anesthesia
- •Known allergy to the study medications
- •Classified as ASA class > II
- •Alpha 2 agonist or antagonist therapy.
研究组 & 干预措施
Control group
Cases will be subjected to spinal anesthesia with hyperbaric bupivacaine 10 mg.
干预措施: Control group (Drug)
Intrathecal group
Cases will be subjected to the same anesthetic mixture as controls with adding dexmedetomidine 5 μg.
干预措施: Intrathecal group (Drug)
Intravenous group
Cases will receive hyperbaric bupivacaine (10 mg), in addition to IV dexmedetomidine (1 μg/kg loading dose, followed by 0.4 μg/kg/h maintenance dose).
干预措施: Intravenous group (Drug)
结局指标
主要结局
Time to first analgesic request
时间窗: 24 hours postoperatively
Time to first analgesic request will be recorded
次要结局
- The degree of motor block(24 hours Postoperatively)
- The onset of sensory(24 hours Postoperatively)
- Total analgesic requirements(48 hours Postoperatively)
- Sedation level(Intraoperativley)
- The incidence of side effects(48 hours Postoperatively)
研究者
Laila Elahwal
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine
Tanta University