Comparison of intrathecal nalbuphine and fentanyl as adjuvants to bupivacaine in spinal anaesthesia in patients undergoing lower limb surgeries.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- two groups-intrathecal nalbuphine &
研究概览
简要总结
Spinal anesthesia remains a popular method of anesthesia for a wide range of surgeries due to its easiness ,safety features and newer addition drugs with less side effects and more benefits for certain patient populations. However, it is also frequently associated with undesirable effects such as hypotension, bradycardia, and shivering. Rarely, it may cause severe bradycardia and cardiac arrest. Adjuvants or additives are often used with local anesthetics for its synergistic effect by prolonging the duration of sensory-motor block, minimize side effects and limiting the cumulative dose requirement of local anesthetics.
Opioids are the time honoured drugs which have been used for this purpose. Nalbuphine is an agonist-antagonist opioid synthesized to produce analgesia without any unwanted µ agonist side effects like respiratory depression, undesirable sedation, nausea, vomiting and urinary retention.
Fentanyl, a synthetic opioid, has fast onset of action following intrathecal administration due to its high lipid soluble nature. It does not tend to migrate to the fourth ventricle in sufficient concentration to cause delayed respiratory depression when administered intrathecally. In this study. Adjuvants are added to prolong post operative analgesia to increase duration of analgesia and to limit the side effects of increased dose of local anesthetics on hemodynamics.
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
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.American society of anaesthesiologist(ASA) status I and II 2.Age 25-65 years 3.both genders.
排除标准
- •1.Patients with contraindication to spinal anaesthesia 2.Pre-existing neurological deficits 3.Patients with history of allergy to study drugs 4.Pregnant patients.
结局指标
主要结局
two groups-intrathecal nalbuphine &
时间窗: Time at which intrathecal drug is administered is | T0, followed by T1 at 1min,T2 at 2 min,T3 at 3 min interval......till intraoperative period followed | by time required for regaining of sensory and | motor sensation in postoperative period.
To evaluate & compare the following factors in
时间窗: Time at which intrathecal drug is administered is | T0, followed by T1 at 1min,T2 at 2 min,T3 at 3 min interval......till intraoperative period followed | by time required for regaining of sensory and | motor sensation in postoperative period.
intrathecal fentanyl as an adjuvant to
时间窗: Time at which intrathecal drug is administered is | T0, followed by T1 at 1min,T2 at 2 min,T3 at 3 min interval......till intraoperative period followed | by time required for regaining of sensory and | motor sensation in postoperative period.
hyperbaric bupivacaine in lower limb
时间窗: Time at which intrathecal drug is administered is | T0, followed by T1 at 1min,T2 at 2 min,T3 at 3 min interval......till intraoperative period followed | by time required for regaining of sensory and | motor sensation in postoperative period.
surgeries with respect to:
时间窗: Time at which intrathecal drug is administered is | T0, followed by T1 at 1min,T2 at 2 min,T3 at 3 min interval......till intraoperative period followed | by time required for regaining of sensory and | motor sensation in postoperative period.
1. Sensory & motor blockade -onset & duration
时间窗: Time at which intrathecal drug is administered is | T0, followed by T1 at 1min,T2 at 2 min,T3 at 3 min interval......till intraoperative period followed | by time required for regaining of sensory and | motor sensation in postoperative period.
次要结局
- Duration of analgesia(perioperative to postoperative period)