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临床试验/CTRI/2025/04/085839
CTRI/2025/04/085839尚未招募4 期

A randomized study to compare the Efficacy and Safety of Intrathecal Dexmedetomidine versus Fentanyl as an adjuvant to Isobaric Levobupivacaine for Elective Lower Limb Orthopaedic Surgery.

Department of Anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月5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
60
试验地点
1
主要终点
1.Onset of sensory block

研究概览

简要总结

Spinal anaesthesia is the most commonly used technique for lower limb orthopaedic surgeries as it is very economical and easy to administer. This is due to the factors like avoiding the risks of general anesthesia such as pulmonary aspiration, bronchospasm, laryngospasm, cardiovascular response to intubation or risk of failed intubation and also allowing a patient to remain awake and enjoy the Painless experience of surgery. It also provides effective pain relief during intra operative and early postoperative period. Spinal anaesthesia also has rapid onset and low failure rate.

Spinal anesthesia is performed by placing a needle between the lumbar vertebrae and through the dura to inject anesthetic medication. Levobupivacaine, a new local anaesthetic, has been recently introduced into clinical practice because of its lower toxic effects for heart and central nervous system. Administrating the combinations of other classes of analgesics with local anesthetics has used to increase the duration and reduce side effects of analgesia. Some drugs have been used as adjuvants in spinal anesthesia to prolong intraoperative and postoperative analgesia including opioids (morphine, fentanyl and sufentanyl to hydromorphone, buprenorphine and tramadol), alpha2 agonists, neostigmine, vasoconstrictors, etc. Clonidine and dexmedetomidine are two alpha2 agonists affecting via pre- and post-synaptic alpha2 receptors.

For this a total of 60 patients (n = 60) undergoing lower limb orthopaedic surgeries will be randomly divided into two groups ( Group A and Group B). Group A patients will receive Isobaric Levobupivacaine 0.5% (3ml) with preservative free Dexmedetomidine 5mcg and Group B patients will receive Isobaric Levobupivacaine 0.5% (3ml) with preservative free Fentanyl 25mcg to subarachnoid block.

Patient will be received in operation theatre, intravenous cannula will be secured and hemodynamic variables will be noted. Surgery will be started after T10 level sensory blockade will achieve. Quantitative values of time of onset and duration of sensory and motor blockade, time taken to achieve maximum sensory blockade will be recorded.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant 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

  • 1.Patients who will give informed written consent.
  • 2.Patients belonging to ASA Class I and II.
  • 4.Patients Height 150-180 cm.
  • 5.Patients Weight 50-80 kg.

排除标准

  • 1.Patients having allergy to study drugs.
  • 2.Patient should not be a part of other study.
  • 3.Non co-operative patients.
  • 4.Patients having absolute contraindications to spinal anaesthesia 5.Patients with Heart disease, Uncontrolled Diabetes mellitus, Morbid obesity, Coagulation Abnormalities and Vertebral deformities 6.Patients using alpha 2-adrenergic receptors antagonists, calcium channel blockers, angiotensin-converting enzyme inhibitor.

结局指标

主要结局

1.Onset of sensory block

时间窗: 1. 0 min | 2. 01 min | 3. 02 min | 4. 03 min | 5. 05 min | 6. 10 min | 7. 15 min | 8. 30 min | 9. 45 min | 10. 60 min | 11. 75 min | 12. 90 min

2.Onset of motor block

时间窗: 1. 0 min | 2. 01 min | 3. 02 min | 4. 03 min | 5. 05 min | 6. 10 min | 7. 15 min | 8. 30 min | 9. 45 min | 10. 60 min | 11. 75 min | 12. 90 min

5.To achieve Maximum sensory block

时间窗: 1. 0 min | 2. 01 min | 3. 02 min | 4. 03 min | 5. 05 min | 6. 10 min | 7. 15 min | 8. 30 min | 9. 45 min | 10. 60 min | 11. 75 min | 12. 90 min

3.Duration of sensory blocks

时间窗: 1. 0 min | 2. 01 min | 3. 02 min | 4. 03 min | 5. 05 min | 6. 10 min | 7. 15 min | 8. 30 min | 9. 45 min | 10. 60 min | 11. 75 min | 12. 90 min

4.Duration of motor block

时间窗: 1. 0 min | 2. 01 min | 3. 02 min | 4. 03 min | 5. 05 min | 6. 10 min | 7. 15 min | 8. 30 min | 9. 45 min | 10. 60 min | 11. 75 min | 12. 90 min

次要结局

  • Hemodynamic changes ( SBP, DBP, MAP, HR, SPO2, RR) and adverse effects associated with drugs under study(1. 0 min)

研究者

发起方
Department of Anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur
申办方类型
Government medical college

研究点 (1)

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