A comparative study to assess the effects of intrathecalfentanyl and intrathecal tramadol combined with 0.5%bupivacaine heavy in patients undergoing electiveurological surgeries: A prospective randomized study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Prolonged duration of analgesia with the addition of
研究概览
简要总结
This is a prospective randomized study to compare and assess the effects of intrathecal fentanyl and intrathecal tramadol combined with 0.5% bupivacaine heavy in patients undergoing elective urological surgeries:
1.To evaluate the duration of analgesia of intrathecal bupivacaine 0.5% heavy with tramadol versus intrathecal bupivacaine 0.5% heavy with
fentanyl. 2. To compare hemodynamic changes in both groups. 3. Incidence of side effects if any.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient giving consent to participate in study and scheduled for elective urosurgery.
- •Age between 20-60 years ASA grade I and II.
排除标准
- •Patients not giving consent to participate in the study.
- •ASA grade III and IV Patients with respiratory, cardiovascular, hepatic and renal diseases, obesity and pregnancy.
- •Age below <20 years and above >60 years.
- •Any bleeding disorder and patient on anticoagulants.
- •Neurological and musculoskeletal disease.
- •Patient already receiving any analgesic.
- •Patient already receiving opioid agonist or antagonist in preceding 6 hrs of surgery.
结局指标
主要结局
Prolonged duration of analgesia with the addition of
时间窗: from induction of spinal anaesthesia to 6 hrs postoperative period
intrathecal fentanyl.
时间窗: from induction of spinal anaesthesia to 6 hrs postoperative period
Stable haemodynamic profile with intrathecal tramadol.
时间窗: from induction of spinal anaesthesia to 6 hrs postoperative period
次要结局
- Lesser side effects with intrathecal tramadol.(from induction of spinal anaesthesia to 6 hrs postoperative period)