Optimal dose of intrathecal dexmedetomidine as an adjuvant to hyperbaric ropivacaine in subarachnoid block in patients undergoing lower abdominal and lower limb surgeries
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare Total duration of analgesia and Post-operative analgesia of intrathecal dexmedetomidine as an adjuvant to hyperbaric ropivacaine in subarachnoid block in patients undergoing lower abdominal and lower limb surgeries
研究概览
简要总结
Introduction:
Subarachnoid block is the most commonly performed block for lower abdominal, perineum and lower limb surgery. Many adjuncts like clonidine, fentanyl, ketamine, tramadol, neostigmine, magnesium sulphate, etc. have been used to prolong motor and sensory block, haemodynamic stability and reduced demand for rescue analgesics in first 24 hours. Dexmedetomidine is a more selective alpha 2 adrenoceptor agonist and has recently been widely used as an adjuvant to intrathecal local anaesthesia.
Advantages/benefits that would accrue out of the research: Intrathecal dexmedetomidine significantly prolongs analgesic effect thus reducing higher doses of local anaesthetic agents, Reduces the requirement of post-operative analgesic, Optimal dose of intrathecal dexmedetomidine prevents adverse effects such as hypotension and bradycardia which is most reported intraoperative and postoperative period
Study procedure:
After getting approval from the ethics and research committee, after applying inclusion and exclusion criteria, informed written consent is obtained, and patients are randomly divided into five groups. All patients received a drug volume of 3.2ml containing 3ml of hyperbaric ropivacaine hydrochloride (7.5mg/ml). The study groups received dexmedetomidine (available as 100mcg/1ml) 5mcg (group D1), 10mcg (group D2) and 15mcg (group D3) in an identical volume of 0.2ml, diluted with normal saline and added to ropivacaine in the same syringe. The control group (Group C) received 0.2ml of NS added to ropivacaine. Insulin syringe (1ml) was used for measuring fluids<1ml.
After arrival into the operation theatre, standard monitor was attached. ECG, pulse oximetry and non-invasive blood pressure were monitored and baseline values were recorded. An intravenous line was secured.
With the patient in sitting position, under all aseptic conditions, lumbar puncture was performed at L2-3 or L3-4 intervertebral space with 25G Quincke spinal needle until free flow of cerebrospinal fluid is seen. The drug is injected intrathecally using a 5ml Syringe.
Time of onset and duration of Motor blockage (using bromage scale), Time of onset and duration of Sensory blockage (using pin-prick method), Time to first rescue analgesia, Intra-operative systolic/diastolic blood pressure, heart rate are recorded.
In postoperative period, Patient vitals and pain score is recorded using VAS scale are recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients scheduled for elective lower abdominal and lower limb surgeries under subarachnoid block in VMMCH, Karaikal.
- •Patients of American Society of Anaesthesiologists (ASA) physical status I and II.
排除标准
- •Patients allergic to any of the drugs used 2) Patients having any absolute contraindications for spinal anesthesia such as patient not willing raised intracranial pressure, severe hypovolemia, bleeding diathesis, local infection and cardiac respiratory, and CNS diseases 3) Patients having hypertension 4) Patients with obesity more than 30kg per meter square 5) Patient with height less than 150cms.
结局指标
主要结局
To compare Total duration of analgesia and Post-operative analgesia of intrathecal dexmedetomidine as an adjuvant to hyperbaric ropivacaine in subarachnoid block in patients undergoing lower abdominal and lower limb surgeries
时间窗: Time of drug given to 10th hour of postoperative period
次要结局
- To compare(1)Onset of sensory blockade)