Comparative Study Between Postoperative Effect Dexmedetomidine or Fentanyl as an Adjuvant to Heavy Bupivacaine in Spinal Anaesthesia in Lower Limb Vascular Surgeries
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- evaluate postoperative effect of using intrathecal dexmedetomidine as an adjuvant to heavy bupivacaine in vascular lower limb surgeries on pain intensity.
研究概览
简要总结
Spinal anaesthesia is an excellent choice of numerous operating procedures. This is due to its effectiveness, rapid onset of action, easy to implement, patient stayed awake, and minimal drug cost.(1) It is also beneficial for patients with chronic airway disorders, reducing the risk of pulmonary aspiration and vomiting in patients with full stomach, as well as its fewer adverse effects, and speedy patient turnover. (2,1) In lower abdominal and lower limb surgeries, spinal anaesthesia is still the primary option. (3) The resultant nerve block is sufficient for patient welfare, while motor block eases the surgeon's work. Moreover, it grants efficient pain relief in the early post-operative period. (2) Yet, postoperative analgesia is a most important dilemma. (4) Thus, additional pain control is essential after spinal anaesthesia effect fades. Consequently, effective analgesia is crucial to accelerate rehabilitation and return to proper functional ability. Post-operative analgesia can be accomplished by numerous approaches specifically systemic opioid and non-opioid, local wound infiltration and peripheral nerve blocks, each approach have its own advantages and drawbacks.
详细描述
Different adjuvants have been added to local anaesthetics in spinal anaesthesia such as adrenaline, midazolam, clonidine, neostigmine, magnesium, and ketamine to extend the analgesic effect duration and to decrease the prevalence of adverse actions, but no one had been reputable in daily clinical practice. (2,4,5) Administration of opioids intrathecal such as fentanyl, morphine, and buprenorphine, allows decrease dose of the local anesthetic drug, augment analgesic effectiveness, and reduces probable toxicity and cardiovascular adverse consequences of local anesthetics. (5,6) Dexmedetomidine is a novel central alpha2-agonist that was approved by the FDA in 1999.It has sedation, anxiolytic, analgesic and sympatholytic effect that depress cardiovascular reflexes in perioperative interval. (6) Thus, this study will be conducted for assessment of the effectiveness of addition 4 µg Dexmedetomidine to hyperbaric Bupivacaine intrathecally in lower limb surgeries.
Aim This clinical comparative study aiming to evaluate postoperative effect of using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb surgeries on pain intensity, analgesic requirement and shivering.
Patients and Methods After approval of medical institutional ethical committee, 40 patients of American Society of Anaesthesiologists (ASA) physical status 1or 2, aged between 20-60 years will be incorporated in this prospective randomized controlled study.
Inclusion Criteria
1- The patient aged range from 20 to 60 years 2- ASA 1 and 2 3- Patient prepared for elective lower limb surgeries. 4- Either sex male or female. Exclusion Criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria
- •The patient aged range from 20 to 60 years
- •ASA 1 and 2
- •Patient prepared for elective lower limb surgeries.
- •Either sex male or female.
排除标准
- •1- Patient refusal. 2- Patient has absolute contraindication to spinal anaesthesia. 3- Patients with ASA 3 or more 4- Patients taking ACE inhibitor, adrenergic receptor antagonist and calcium channel blocker.
- •5-Patients with head injury and polytrauma.
研究组 & 干预措施
Group D
干预措施: 4 µg dexmedetomidine in 0.5 mL of normal saline intrathecal (dexmedetomidine 100 µg/mL will be diluted in 12.5 ml preservative-fr (Drug)
Group F
干预措施: fentanyl (Drug)
结局指标
主要结局
evaluate postoperative effect of using intrathecal dexmedetomidine as an adjuvant to heavy bupivacaine in vascular lower limb surgeries on pain intensity.
时间窗: 7 hours
Pain had been assessed firstly every 1 hour for first 4 hours and subsequently till the patient required analgesia by means of "Visual Analogue Scale", It is lined scale, entails a 10 cm line attached at one end by a marker such as "No pain" and the other end by "Worst pain comprehendible". Patient just made mark on the line to denote the intensity of pain
evaluate postoperative effect of using intrathecal dexmedetomidine as an adjuvant to heavy bupivacaine in vascular lower limb surgeries on analgesic requirements
时间窗: 7 hours
First analgesic requirement time was defined as from the time of spinal injection to the time the patient requires analgesia. The rescue analgesic used was Tramadol 50mg IV for visual analogue score of more than 4.
evaluate postoperative effect of using intrathecal dexmedetomidine as an adjuvant to heavy bupivacaine in vascular lower limb surgeries on shivering. Remove
时间窗: 7 hours
The incidence and intensity of shivering would be also assessed postoperatively in the recovery room using the method of Tsai and Chu as follows: 0, no shivering 1. peripheral vasoconstriction without visible shivering 2. muscular activity in only one muscle group 3. muscular activity in more than one muscle group 4. shivering involving the whole body.
次要结局
- Complications would be noted post-operative(7 hours)
研究者
Nashwa Ahmed
, Lecturer of Anaesthesia and Surgical Intensive Care, Faculty of Medicine, Port Said University, Egypt
Port Said University hospital