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临床试验/CTRI/2025/01/079224
CTRI/2025/01/079224尚未招募4 期

A Randomized Controlled Study To Evaluate The Effects With Or Without Intravenous Dexmedetomidine As A Pre Medication On Sensory Block Induced By Spinal Anesthesia With 0.5 Percent Hyperbaric Bupivacaine In Lower Limb Surgeries SMS Medical College Jaipur

Department Of Anaesthesia Sawai Man Singh Medical College and Attached Hoapital Jaipur1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年2月10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
66
试验地点
1
主要终点
Mean onset and duration of sensory blockade

研究概览

简要总结

Spinal anesthesia is a type of regional anesthesia which is commonly used technique for lower abdominal , lower limb surgeries. Spinal anesthesia with bupivacaine is the  most preferred technique of anesthesia . Bupivacaine when used in recommended doses, under spinal anesthesia produces complete sensory and motor blockade. Various adjuvants like dexmedetomidine , opioids are added to enhance the effects of the local anesthetics .Dexmedetomidine potentiates the anesthetic effects of all intraoperative anesthetics, regardless of method of administration .Recent studies show  that dexmedetomidine prolongs the sensory  blockade induced by spinal anesthesia . 

For this a total of 66 patients(n=66) undergoing lower limb surgeries will be randomly divided into two groups(Group A and Group B).Group A patients will receive 10 ml 0.9% normal saline as infusion over 10 minutes ,20 minutes prior to subarachnoid block with 15 mg 0.5% hyperbaric bupivacaine and Group B patients will receive 1mcg/kg body weight dexmedetomidine in 10 ml 0.9% normal saline as infusion over 10 minutes, 20 minutes prior to subarachnoid block. 

Patient will be received in operation theatre , intravenous cannula will be secured and hemodynamic variables will be noted .Loading dose of intravenous dexmedetomidine and normal saline as per study group will be given.

Surgery will be started after T10 level sensory blockade is achieved. Quantitative values of time of onset and duration of sensory and motor blockade ,time taken for sensory regression and request of first rescue analgesia will be recorded.

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 50.00 Year(s)(—)
性别
All

入选标准

  • 1.Written Informed Consent 2.Age group of 18 to 50 years 3.Both genders 4.Patients of ASA Grade I and II 5.Weight of Patient 50 to 90 kg 6.Patients undergoing lower limb surgeries 7.Height of Patient more than 150 cm.

排除标准

  • 1.Patient with history of drug allergy to local anaesthestics 2.Patient with coagulation disorders or taking anticoagulant drugs 3.Patient on alpha 2 agonists and beta blockers 4.Patient with history of heart blocks ,heart rate less than 50 per minute and dysrhytmias 5.Patient with uncontrolled metabolic disease 6.Psychologically unstable patients with preexisting neurological deficits 7.Patient with Spinal Deformities 8.Patient not included in any other study.

结局指标

主要结局

Mean onset and duration of sensory blockade

时间窗: 1.0 min | 2.2 min | 3.4 min | 4.6 min | 5.8 min | 6.10 min | 7.25 min | 8.40 min | 9.55 min

次要结局

  • Mean onset of motor blockade(minutes)(Mean duration of motor blockade(minutes))

研究者

发起方
Department Of Anaesthesia Sawai Man Singh Medical College and Attached Hoapital Jaipur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Shriphal Meena

Sawai Man Singh Medical College

研究点 (1)

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