Comparison of efficacy, BIS value and haemodynamic spectrum of levobupivacaine 0.5% versus ropivacaine 0.75% with dexmedetomidine as an adjuvant following lumbar epidural anaesthesia in long bone surgeries
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 1.Characteristic of motor & sensory block (min)
研究概览
简要总结
STUDY TITLE: Comparison of efficacy, BIS value and Haemodynamic spectrum of Levobupivacaine 0.5% vs Ropivacaine 0.75% with dexmedetomidine as an adjuvant following Lumbar epidural anaesthesia in long bone surgeries .
RATIONALE : Is there any difference in the clinical efficacy BIS value and haemodynamic spectrum of epidural 0.5% levobupivacaine and 0.75% ropivacaine with dexmedetomidine as an adjuvant on the level of duration of sensory and motor blockade following lower limb surgeries?
Is there any significant difference in the incidence of adverse events following epidural anaesthesia with administration of 0.5% levobupivacaine and 0.75% ropivacaine?
AIM: To compare the clinical efficacy, BIS value and Haemodynamic spectrum of Levobupivacaine 0.5% vs Ropivacaine 0.75% with dexmedetomidine as an adjuvant following Lumbar epidural anaethesia in long bone surgeries
OBJECTIVES: Efficacy , BIS value and Haemodynamic spectrum of test drugs The level and duration of sensory and motor block
STUDY PLACE: B.R.L.S.A.B.V.M.Medical college ,Rajnandgaon
STUDY DESIGN: Prospective Randomized interventional double blind study TIME FRAME:
April 2024 –June 2024
STUDY APPROVAL : Institutional Scientific & Ethics Committee POPULATION/PARTICIPANTS: Patients scheduled for elective surgeries at B.R.L.S.A.B.V.M. Medical college, Rajnandgaon from April 2024 – June 2024
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 to 65 year ASA I-II BMI (18.5-35) Either gender Patients undergoing elective long bone surgeries.
排除标准
- •Patient refusal Bilateral lower limb surgeries Focal neurological deficits Inability to understand VAS Coagulation disorders Severe spinal deformities Infection at the site of block Pre existing peripheral neuropathy Uncontrolled Diabetes mellitus Known hypersensitivity to Local anaesthetics.
结局指标
主要结局
1.Characteristic of motor & sensory block (min)
时间窗: SENSORY BLOCK | 1: Onset time to T10 - time taken for sensory blockade to pain at T10 level since the time of Drug injection by Pin Prick Method | 2: Maximal sensory level | 3: Time to maximal Sensory level | 4: Time to two dermatome regression | 5: Time to regression to T10 6: Time to regression to L1 | MOTOR BLOCK | 1 :Time to complete block as per Modified Bromage Scale | 2 :Time to complete recovery | BIS Score Index :0 to 180 min
2.BIS index score
时间窗: SENSORY BLOCK | 1: Onset time to T10 - time taken for sensory blockade to pain at T10 level since the time of Drug injection by Pin Prick Method | 2: Maximal sensory level | 3: Time to maximal Sensory level | 4: Time to two dermatome regression | 5: Time to regression to T10 6: Time to regression to L1 | MOTOR BLOCK | 1 :Time to complete block as per Modified Bromage Scale | 2 :Time to complete recovery | BIS Score Index :0 to 180 min
次要结局
- 1.Incidence of adverse effects 2.Requirements of 1st Rescue analgesic(3.Duration of analgesia 4.Patient satisfaction)
研究者
Dr Poonam Lata Singh Thakur
Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon