Comparative Analysis of Intraoperative Effect Dexmedetomidine and Fentanyl as an Adjuvant to Heavy Bupivacaine in Spinal Anaesthesia in Lower Limb Orthopedic Surgeries.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- to evaluate duration of motor block of using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopedic surgeries.
研究概览
简要总结
Spinal anesthesia is the most widely employed procedure for lower limb orthopedic operations, as it is very cost-effective and simple to apply. These advantages could be restricted because presently existing local anesthetic drugs had relatively short length of action. (1) Spinal anesthesia with 0.5% heavy bupivacaine (hyperbaric) is a common technique, still there was burden of its short duration of action. To overcome this issue, there was a continuous search for an ideal adjuvant.(2) Adjuvants were mostly added to local anesthetic drugs to increase their effectiveness, speedy onset, increase the period of the block, and reduce the local anesthetics dosage, thus reduction their adverse effects.(3) Such adjuvants had been beneficial in extension of analgesia along with initiation of movement though their related side effects.(4)
详细描述
Administration of opioids intrathecal such as fentanyl, morphine, and buprenorphine, allowed decreasing dose of the local anesthetic drug, augment analgesic effectiveness, and reduce probable toxicity and cardiovascular adverse consequences of local anesthetics. (5, 2) Nevertheless, adverse effects such as possibly disastrous delayed respiratory depression, urinary retention, nausea, pruritus, vomiting, and constipation had provoked further study to investigate non opioid analgesic drugs with less troublesome drawbacks. (6,2,7,8) Dexmedetomidine is a novel central alpha2-agonist that was approved by the FDA in 1999. It had sedation, anxiolytic, analgesic, and sympatholytic effect that depress cardiovascular reflexes in perioperative interval. (2) Thus, this study had been conducted for assessment of the effectiveness of addition 4 µg Dexmedetomidine to hyperbaric Bupivacaine intrathecally in lower limb orthopaedic surgeries.
Aim This clinical comparative study aimed to evaluate the hemodynamic stability and onset and duration of motor block of using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopaedic surgeries.
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 had been 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 orthopaedic surgeries. 4. Height 150-180 cm. 5. Weight 50-70 kg. 6- 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
- •The patient aged range from 20 to 60 years
- •ASA 1 and 2
- •Patient prepared for elective lower limb orthopaedic surgeries.
- •Height 150-180 cm.
- •Weight 50-70 kg. 6- Either sex male or female.
排除标准
- •- 1- Patient refusal. 2- Patient had absolute contraindication to spinal anaesthesia. 3-Patients with neurological disorders, pregnancy, local infection at the site of injection.
- •4- Patients suffering from dysrhythmia or heart block. 5- Patients with ASA 3 or more.
研究组 & 干预措施
Group D
干预措施: Dexmedetomidine (Drug)
Group F
干预措施: fentanyl (Drug)
结局指标
主要结局
to evaluate duration of motor block of using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopedic surgeries.
时间窗: 7 hour
Duration of motor block had been evaluated by the time taken to return from complete Bromage motor block (bromage 3) to scale 0. Motor block was evaluated with Modified Bromage scale (6) Bromage 0: The patient could move the hip, knee, and ankle. Bromage 1: The patient could move the hip but had ability to move the knee and ankle. Bromage 2: The patient could move the hip and knee but had ability to move the ankle. Bromage 3: The patient could not move the hip, knee, and ankle.
evaluate onset of motor block of using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopedic surgeries.
时间窗: 10 minutes
onset time of bromage 3 motor block had been recorded (Onset of the motor block; period between the ending of intrathecal drug injection and entire motor paralysis)
to evaluate non invasive mean blood pressure using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopedic surgeries.
时间窗: 90 minutes
Intraoperatively non-invasive mean blood pressure had been documented, every 15 min for first 30minutes then every 30 min till the end of the surgery.
to evaluate the heart rate using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopedic surgeries.
时间窗: 90 minutes
Intraoperatively heart rate had been documented, every 15 min for first 30minutes then every 30 min till the end of the surgery.
次要结局
- Complications would be noted Intraoperative(90 minutes)
研究者
Nashwa Ahmed
, Lecturer of Anaesthesia and Surgical Intensive Care, Faculty of Medicine, Port Said University, Egypt
Port Said University hospital