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临床试验/CTRI/2024/11/076796
CTRI/2024/11/076796尚未招募4 期

Comparison of Subarachnoid Block in Mixed Versus Sequential Administration of Levobupivacaine and Dexmedetomidine in Lower Limb Surgeries: A Randomized Clinical Study

Goverment Medical college Baroda1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2024年11月24日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
58
试验地点
1
主要终点
Sensory and Motor blockade characteristics

研究概览

简要总结

The aim behind performing this study is to see differences in sensory and motor block characteristics along with determining effects on haemodynamics while intrathecal administration of premix hyperbaric Levobupivacaine and Dexmedetomidine in single syringe or in two separate syringes.

58 patients for lower limb surgeries will be randomly decided into two groups , In each group there will be 29 patients who are posted for elective lower limb surgeries.

In one group Group M -  - Inj Levobupivacaine 0.5% (12.5mg) 2.5ml + Inj Dexmedetomidine (10mcg) 0.5 ml (Diluted in Normal saline).  (premix). Total drug prepared will be 3ml in a single 5cc syringe. In second group Group S - Inj Levobupivacaine 0.5% (12.5mg) 2.5 ml (in 5cc syringe) followed by Inj Dexmedetomidine (10mcg) 0.5ml (Diluted in Normal saline in 2cc syringe). (Two syringe technique – drugs will be loaded in two separate syringes).

Comparing Sensory and Motor block characteristics as primary outcome

As a secondary outcome  , hemodynamic parameters ,duration of effective analgesia , requirement of rescue analgesia in 24 hours ,any complications will be assessed .

The proposed advantage of the study will be that Dexmedetomidine and Levobupivacaine given sequentially results in faster onset of sensory and motor block, prolongs the duration and reduces the postoperative analgesic requirement as compared to premixed drugs .

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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 – I/II/III Lower limb surgeries Duration of surgery: 2 to 2.5 hrs.

排除标准

  • Patients refusal.
  • Patients with absolute and relative contraindications to spinal anaesthesia Local skin infection, Vertebral column abnormalities, bleeding disorders, cardiopulmonary disease, neuropathies Patients with allergy to study drugs.
  • Pregnant and lactating females.
  • BMI more than 30kg/ m2.

结局指标

主要结局

Sensory and Motor blockade characteristics

时间窗: Till 24 hours

Onset of sensory block at L1 dermatomal level

时间窗: Till 24 hours

Time to achieve maximum sensory level

时间窗: Till 24 hours

Time for two segment regression

时间窗: Till 24 hours

Total duration of sensory block

时间窗: Till 24 hours

Onset of motor blockade

时间窗: Till 24 hours

Time to achieve maximum motor blockade

时间窗: Till 24 hours

Duration of motor blockade

时间窗: Till 24 hours

次要结局

  • To observe any changes in hemodynamic parameters like pulse rate, systolic blood pressure, diastolic blood pressure, mean areterial pressure, SpO2 perioperatively.(Duration of effective analgesia - time from administration of drug intrathecally to pain score VAS ≥ 4 postoperatively.)

研究者

发起方
Goverment Medical college Baroda
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Pooja Parma

Goverment Medical college Baroda

研究点 (1)

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