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临床试验/CTRI/2024/11/076475
CTRI/2024/11/076475尚未招募2/3 期

Efficacy of Different Doses of Dexmedetomidine Intrathecally as an Adjuvant to Low Dose Hyperbaric Levobupivacaine in Urological Procedures: A Comparative Study to Determine the Optimal Dose

Sri Guru Ram Das Institute of Medical Sciences and Research1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年11月11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 assess the duration of post operative analgesia by three different doses of dexmedetomidine when used as adjuvant to low dose hyperbaric levobupivacaine in spinal anaesthesia using VAS Score

研究概览

简要总结

Introduction: Effective perioperative pain management in urological procedures is imperative for patient comfort and postoperative recovery. This study seeks to address this need by investigating the efficacy and safety of varying doses of intrathecal dexmedetomidine as an adjuvant to low-dose hyperbaric levobupivacaine for enhancing postoperative analgesia while maintaining hemodynamic stability. Aims & Objectives: The primary aim of this prospective, randomized, double-blind study is to determine the optimal dose of dexmedetomidine which prolongs postoperative analgesia, by comparing three varying doses. We aim to assess their respective abilities reduce the need for rescue analgesia, and minimize adverse effects in patients undergoing spinal anaesthesia for urological procedures. Methodology: 90 patients, aged 18-75y, will be randomized into three groups of 30 patients each. Each will receive hyperbaric levobupivacaine 2.2 ml with 5 µg ,7.5 µg and 10 µg of dexmedetomidine in group A, B and C respectively, diluted to 2.4 ml with 0.9 ml normal saline. After comprehensive pre-anaesthetic evaluation, standardized drug preparation, and a meticulous anaesthesia technique, continuous monitoring of vital signs, onset of sensory and motor block, and occurrence of adverse events will be noted intraoperatively. Postoperatively, the duration of analgesia, frequency of rescue analgesia, and incidence of side effects will be recorded. Significance: This study has potential to contribute to the development of tailored perioperative pain management protocols. By elucidating the most effective dose of dexmedetomidine, this research may lead to reduced opioid consumption, improved patient satisfaction, and enhanced postoperative recovery. Furthermore, the findings may offer valuable insights into optimizing pain control strategies for geriatric patients with multiple comorbidities undergoing urological surgeries under spinal anaesthesia.

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 75.00 Year(s)(—)
性别
All

入选标准

  • 1.ASA Physical status I.
  • II 2.Patients undergoing Transurethral resection of prostate, Ureteroscopic lithotripsy,Cystoscopy, Other urological procedures under spinal anaesthesia.

排除标准

  • 1.Known hypersensitivity to study drugs.
  • 2.History of coagulopathy 3.Skin infection at spinal site 4.Spine deformity 5.Major Co-morbidities (hepatic, renal and cardiovascular) 6.Pregnant female.

结局指标

主要结局

To assess the duration of post operative analgesia by three different doses of dexmedetomidine when used as adjuvant to low dose hyperbaric levobupivacaine in spinal anaesthesia using VAS Score

时间窗: from completion of surgery till 12 hours postoperative

次要结局

  • 1.To measure time to first request and total number of rescue analgesia postsurgery in first 12 hours in each group.

研究者

发起方
Sri Guru Ram Das Institute of Medical Sciences and Research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Lakshmi Mahajan

Sri Guru Ram Das Institute of Medical Sciences and Research

研究点 (1)

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