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临床试验/CTRI/2026/02/104367
CTRI/2026/02/104367尚未招募3 期

A Randomized Comparative Study to Evaluate the Effects and Safety of Intrathecal Fentanyl Versus Intrathecal Dexmedetomidine as Adjuvants to 0.5 Percent Hyperbaric Levobupivacaine in Patients Undergoing Infraumbilical Surgeries Under Spinal Anaesthesia

Dr Sapna Bansal Professor and Head Department Of Anaesthesia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年3月3日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1

研究概览

简要总结

This randomized , double blind , pospective study is designed to evaluate the comparative effects and safety of adding fentanyl or dexmedetomidine to 0.5% hyperbaric levobupivacaine for spinal anaesthesia in patients undergoing infraumbilical surgeries . Spinal Anaesthesia involves the administration of local anesthetic directly into cerebrospinal fluid within the sub arachnoid space , producing reversible sensory and motor blockade . The distribution and height of the block are influenced by the density of the anesthetic solution relative to CSF, as well as patient positioning . hyperbaric solutions , creating by adding dextrose to levobupivacaine , are denser than CSF, allowing more predictable spread of anesthesia and better control over the block level. Levobupivacaine, the S enantiomer of bupivacaine , offers similar anesthetic potency with reduced cardiotoxicity and neurotoxicity compared to racemic bupivacaine , making it a safer option for spinal anaesthesia. To enhance the quality and duration of anesthesia, adjuvants like fentanyl , a lipophilic opioid, and dexmedetomidine , a selective alpha2- adrenergic agonist, can be added.Fentanyl provides rapid onset analgesia with minimal motor block, while dexmedetomidine prolongs sensory and motor blockade and may improve postoperative analgesia with stable hemodynamics. In this study , patient will receive either 5mcg demedetomidine or 25mcg fentanyl added to 3ml of 0.5percent hyperbaric levobupivacaine. The primary outcomes include the onset , duration and highest level of sensory block, as well as the degree and duration of motor block, while secondary outcomes include hemodynamic changes. The study aims to determine the superior adjuvant for providing safe, effective and prolonged spinal anaesthesia in infraumbilical surgeries

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator 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

  • Age 18-60 years 2) American Society of Anesthesiologist physical status 1 or 2 3) Patients undergoing infraumbilical surgeries.

排除标准

  • Negative consent by the patient
  • contraindication to spinal anaesthesia , (such as coagulopathy , infection at injection site , hypotension , disease or deformity of spine )
  • psychiatric patient 4.ASA status III/IV
  • known sensitivity to drug.

研究者

发起方
Dr Sapna Bansal Professor and Head Department Of Anaesthesia
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Priyam Gandhi

MM Institute of Medical Sciences and Research Centre

研究点 (1)

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