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临床试验/CTRI/2024/03/064440
CTRI/2024/03/064440尚未招募4 期

Intrathecal dexmedetomidine versus nalbuphine as adjuvant to levobupivacaine among patients undergoing infraumblical surgeries in tertiary care hospital

Sree Balaji medical College and hospital1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年3月28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
34
试验地点
1
主要终点
onset of sensory and motor block ,

研究概览

简要总结

Introduction: Adjuvants to local anaesthetics have synergistic action and intensify sensory block without increasing sympathetic block, reduced local anaesthetic drug dose, better hemodynamic stability with lesser side effects.

Levobupivacaine is a local anaesthetic amide which can produce better sensory and motor block with good hemodynamic profile and lesser cardio toxicity than bupivacaine.

Dexmedetomidine an α2-adrenergic agonist and Nalbuphine, a synthetically prepared opioid are two drugs which can be used as adjuvants with local anaesthetic

By combining these adjuvants to local anaesthetic drugs, one can lower the dose of local anaesthetic agent and maintain analgesic efficacy while reducing the incidence and severity of side effects.

Dexmedetomidine mediates its analgesic effects via spinal α2 receptors by depressing the release of C-fiber neurotransmitters and by hyperpolarization of postsynaptic dorsal horn neurons

Until now, there is no specific recommended dose of dexmedetomidine for intrathecal administration. Dose can be varied from 3 to 15 µg as an adjuvant to local anaesthetic in spinal anesthesia.

Nalbuphine is a highly lipid-soluble opioid analgesic and mixed synthetic agonist-antagonist, which attenuates the μ-opioid effects and enhances the κ-opioid effects to provide reasonably potent analgesia of visceral nociception

Intrathecal nalbuphine prolongs the duration of postoperative analgesia when used as an adjunct, and prolongs early postoperative analgesia without increasing the risk of side-effects. Its peak analgesic effects with minimal side effects at doses ranges from 0.4 to 1.6 mg .

Methodology: In this study , Patient will be administered spinal anaesthesia with 0.5% hyperbaric Levobupivacaine 2.8ml with DEXMEDETOMIDINE 5mcg or NALBUPHINE 0.5mg as an adjuvant ( total = 3ml )

The purpose of this study is to compare the efficacy of intrathecal DEXMEDETOMIDINE and NALBUPHINE as an adjuvant to 0.5% hyperbaric levobupivacaine in patients undergoing infraumbilical surgeries under sub arachnoid block by observing the time of onset of sensory and motor block , time taken for highest sensory block , time taken for sensory regression, time of regression to level T10 . The secondary objectives are time of rescue analgesic and intraoperative hemodynamic stability.

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
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • All elective infraumblical surgeries ASA grade 1 and 2.

排除标准

  • Patient refusal History of allergy to study drugs Local site infection History of spinal surgeries, spinal deformities Coagulopathy Dysrhythmia BMI more than 35 Height less than 150 cm.

结局指标

主要结局

onset of sensory and motor block ,

时间窗: 1. Time of administration of drug | 2. Onset of sensory block | 3. Onset of motor block | 4. Time of regression of sensory block to T10 | 5. Time of recovery of motor block to modified bromage scale 2

Duration of sensory and motor block

时间窗: 1. Time of administration of drug | 2. Onset of sensory block | 3. Onset of motor block | 4. Time of regression of sensory block to T10 | 5. Time of recovery of motor block to modified bromage scale 2

次要结局

  • Duration of analgesia(Time of administration of first dose of rescue analgesia)

研究者

发起方
Sree Balaji medical College and hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sateesh kumar J

Sree balaji medical College and hospital

研究点 (1)

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