The Effect of Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort: A Randomized, Triple-Blind Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The incidence of catheter-related bladder discomfort (CRBD)
研究概览
简要总结
The insertion of a urinary catheter in a patient undergoing a surgical procedure, especially urinary interventions, may lead to catheter-related bladder discomfort (CRBD) with varying degrees of severity during the postoperative period. Paracetamol is a drug with proven efficacy for the management of mild and moderate postoperative pain. Tramadol is a centrally acting, synthetic opioid analgesic with weak opioid agonist properties. It inhibits the detrusor activity by inhibition of type-1 muscarinic (M1) and type-3 muscarinic (M3) receptors. Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, with analgesic, sedative, anxiolysis, sympatholytic, and sedative properties, is a very useful associated agent for general anesthesia.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age from 20 - 50 years
- •ASA (The American Society of Anesthesiologists) I or II,
- •undergo percutaneous nephrolithotomy (PCNL)
排除标准
- •Patients with history of psychotic illnesses
- •Opioid users
- •Bladder obstruction,
- •Benign prostatic hyperplasia
- •Overactive bladder (OAB) defined as frequency _3 times at night or _8 times within 24 hours.
研究组 & 干预措施
DP group
Group I (DP group) will receive dexmedetomidine 0.5 mic/kg and paracetamol 10mg/kg
干预措施: Dexmedetomidine 0.5 mic/kg (Drug)
DP group
Group I (DP group) will receive dexmedetomidine 0.5 mic/kg and paracetamol 10mg/kg
干预措施: Paracetamol 10mg/kg (Drug)
TP group
Group II (TP group) will receive tramadol 1mg/kg and paracetamol 10mg/kg.
干预措施: Tramadol 1mg/kg (Drug)
TP group
Group II (TP group) will receive tramadol 1mg/kg and paracetamol 10mg/kg.
干预措施: Paracetamol 10mg/kg (Drug)
结局指标
主要结局
The incidence of catheter-related bladder discomfort (CRBD)
时间窗: 24 hours postoperative
The incidence of catheter-related bladder discomfort (CRBD) will be assessed at 30 minutes and 1, 2, 4, 6,8,10,12 and 24 hours postoperatively.
次要结局
- Postoperative pain(24 hours postoperatively)
- Surgeon satisfaction(24 hours postoperatively)
- Meperidine requirement(24 hours postoperatively)
- Patient satisfaction(24 hours postoperatively)
研究者
Neveen Abd El Maksoad Kohaf
Lecturer of Clinical Pharmacy
Al-Azhar University