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临床试验/CTRI/2022/07/043635
CTRI/2022/07/043635尚未招募2/3 期

To Compare The Post Operative Analgesic effect Of Two Different Doses Of Magnesium Sulphate As An Adjuvant To Levobupivacaine In Sub-Arachnoid Block for Infra-Umbilical Surgeries

SGRDIMSAR1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年2月7日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
To Compare Post Operative Analgesic effect of Two Different Doses of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Sub-Arachnoid Block for Infra-Umbilical Surgeries

研究概览

简要总结

Hyperbaric bupivacaine 0.5% iscommonly used in spinalanesthesia. Hyperbaric solutions may cause sudden cardiac arrest due tohypotension, bradycardia because of higher extend of sympathetic blockade. Theuse of isobaric solutions may decrease these risks. LEVOBUPIVACAINE is newerdrug and should be  preferred duringspinal anesthesia due to its lower cardiovascular side-effects and centralnervous system toxicity. Intrathecal adjuvants are commonly used to improve thequality of intraoperative analgesia and extend it in the postoperative periodwithout significant motor or autonomic blockade.

Thestudy will consist of 90 patients randomly divided into three groups of 30each- group A:0.5% Isobaric LEVOBUPIVACAINE15mg + 100mg magnesium sulphate diluted in N.S(0.2ml),group B: 0.5% isobaric LEVOBUPIVACAINE 15mg +75mgmagnesium sulphate diluted inN.S. (0.2 ml)and group C: only isobaric LEVOBUPIVACAINE 0.5%+0.2ML(NS)intrathecally. These groups will be compared with respect to onset and durationof sensory and motor blockade, duration of postoperative analgesia, sedationscore, side effects and complications.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
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 undergoing infra-umbilical surgeries American Society of Anesthesiology (ASA) Grade I and II Hemodyanamically stable.

排除标准

  • 1.Neurological and musculoskeletal disease.
  • 2.Patients with cardiovascular diseases.
  • 3.Contraindications to regional anesthesia such as patient refusal, local infections/sepsis at the site of lumbar puncture, anatomical disorders of spine, shock, any bleeding disorder and patient on anticoagulants.
  • 4.Hypersensitivity to study drugs 5.Pregnant women.

结局指标

主要结局

To Compare Post Operative Analgesic effect of Two Different Doses of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Sub-Arachnoid Block for Infra-Umbilical Surgeries

时间窗: from the time of giving spinal anaesthesia till 24 hours postopertively

次要结局

  • Complications(from the time of giving spinal anaesthesia till 24 hours postopertively)

研究者

发起方
SGRDIMSAR
申办方类型
Research institution and hospital

研究点 (1)

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