Comparison of Intrathecal Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine on Post-operative Urinary Retention in Knee Joint Arthroscopic Surgeries
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Post-operative urinary retention
研究概览
简要总结
The aim of this study was to assess the effect of intrathecally injected 5 µg dexmedetomidine or 25 µg fentanyl as adjuvants to bupivacaine in low dose spinal anesthesia for unilateral arthroscopic knee surgeries, on post-operative urinary retention (POUR), time needed to reach sensory block at the tenth thoracic dermatome (T10), the maximum sensory level achieved, the onset of motor block, the intra-operative fluids given, the duration of sensory and motor blocks, time to micturition or insertion of an intermittent urinary catheter and the number of patients who needed an indwelling (Foley's) catheter. Seventy patients, ASA physical status I or II, from 21 to 50 years old, scheduled to undergo unilateral arthroscopic knee surgeries under spinal anesthesia, were randomly divided into two equal groups; the Bupivacaine- Dexmedetomidine group (BD) patients and the Bupivacaine-Fentanyl group (BF) patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA physical status I and II
- •aged 21-50 years
- •scheduled to undergo unilateral arthroscopic knee surgeries under spinal anesthesia
排除标准
- •Patients' refusal
- •contraindications to spinal anesthesia
- •patients with coagulopathy
- •infection at the lumbar region
- •pre-existing neurological deficits in the lower limbs
- •known allergy to any of the study drugs
- •urinary incontinence
- •cysto-ureteric reflux
- •patients with congestive heart failure
- •patients with dysrhythmia
- •patients with heart block
- •diabetic patients
- •patients on α2-adrenergic receptors antagonists
- •calcium channel blockers
研究组 & 干预措施
Bupivacaine-Dexmedetomidine group
干预措施: hyperbaric bupivacaine and dexmedetomidine (Drug)
Bupivacaine-Fentanyl group
干预措施: Bupivacaine-Fentanyl group (Drug)
结局指标
主要结局
Post-operative urinary retention
时间窗: 3 hours
Ultrasound assessment of the urinary bladder volume was done at the 3rd post-operative hour, a bladder volume of \>700 ml with no ability to void confirmed the presence of urinary retention
次要结局
- Time to micturition or insertion of an intermittent urinary catheter(6 hours)
- Maximum sensory level achieved(30 minutes)
- Number of patients who needed an indwelling (Foley's) catheter(6 hours)
- Time to reach sensory block at T10(30 minutes)
- Duration of sensory block(6 hours)
- The onset of motor block(30 minutes)
- Intra-operative fluids given(3 hours)
- Duration of motor block(6 hours)
研究者
Ghada M.Samir
Assistant Professor of Anesthesia
Ain Shams University