Comparison of Intrathecal Hyperbaric Ropivacaine 0.5% with and without 75 mg of Magnesium Sulphate as an adjuvant for Infraumblical Surgeries-A Double Blind Randomised Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Total duration of sensory loss.
研究概览
简要总结
Spinal anesthesia is a preferable anesthesia technique for various day-care orthopedic, obstetric and lower abdominal surgeries.Hyperbaric Lignocaine was commonly used for ambulatory procedures due to its short duration of action, but numerous reports of Transient Radicular Irritation (TRI) was reported after its use. Ropivacaine, (Approved by European Union for intrathecal use in 2004) has been demonstrated to provide safe and reliable spinal anesthesia of intermediate duration, with relatively shorter duration of motor blockade compared to Bupivacaine; encouraging earlier mobilization in patients.Due to difficulty in maintaining pharmacological stability of hyperbaric Ropivacaine, currently only isobaric solution are available. But Ropivacaine, made hyperbaric by adding desired quantity of Dextrose, has been compared with isobaric solution for spinal anesthesia, and a predictable block with better cephalad spread and a quicker sensory and motor regression with the former has been proven.Opioid adjutants have been used with intrathecal Ropivacaine for extending duration of block and their associated side effects like nausea, vomiting, bladder retention, purities, paralytic ileus and respiratory depression have been noted.Intrathecal Magnesium sulphate, has been used in humans since 1906.10 It is a non competitive antagonist of N-methyl-D-aspartate (NMDA) glutamate and inositol triphosphate-gated calcium channels, and it blocks the spinally mediated facilitatory component evoked by repetitive C-fibre stimulation (activity dependant increase in excitability of spinal neurons). This can prevent and abolish central sensitisation.Ropivacaine is emerging as a local anesthetic of choice to provide spinal anesthesia for day care surgeries of shorter duration and Magnesium sulphate is a non opioid adjuvant devoid of various undesirable effect; and hence, we decided to conduct this randomised trial to demonstrate the effects of Magnesium Sulphate as an adjuvant to intrathecal hyperbaric Ropivacainefor infra umbilical surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA 1 and 2 patients, Patients posted for all infraumblical surgeries of approximatly 2 hours duration, Minimal expected bloods loss surgeries.
排除标准
- •Patient unwilling to participate, Pregnant and breast feeding mothers, Patient with coagulation or bleeding disorders, Local spinal site infection, Spinal abnormalities or spinal instrumentation procedures, BMI>30, Patient posted for surgeries for more than 2 hours duration, Patients with unstable hemodynamics.
结局指标
主要结局
Total duration of sensory loss.
时间窗: 2 mins for first 10 mins,there after every 5 mins till fixation level is acheived.Every 15 mins till regression to T10 level thereafter every 30 mins till complete regression to S2 level.
次要结局
- a)Total duration of motors blockade,(b)Quality of post op analgesia,)