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临床试验/CTRI/2024/08/072850
CTRI/2024/08/072850招募中不适用

Clonidine Versus Dexmedetomidine As Premedication to Intrathecal 0.5percent Levobupivacaine Heavy

velammal medical college and hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
onset of sensory block

研究概览

简要总结

Spinal anesthesia is a reliable and safe technique in lower limb and lower abdominal surgeries.[1] It is favorable when general anesthesia is contraindicated or in patients in whom anatomical abnormalities may make tracheal intubation very difficult.[2] Many techniques and drug regimens, with partial or greater success, have been tried from time to time to alleviate anxiety and prolong postoperative analgesia during regional anesthesia. Several adjuvants such as midazolam, opioids, and α2-adrenoceptor agonists have been studied in this regard. When used as adjuvant to regional anesthesia, alpha-2-adrenoceptor agonists have both analgesic and soothing properties.[ Clonidine and dexmedetomidine are the two most used drugs. Oral, spinal, and epidural are the various routes of administration of these drugs to prolong the duration of spinal anesthesia.[5-7] They prolong the duration of both motor and sensory blockade and also postoperative analgesia by potentiating the effect of local anesthesia Both spinal and supraspinal mechanisms have been proposed to explain their action. In the spinal cord, stimulation of α-adrenoreceptors at the substantia gelatinosa of the dorsal horn of the spinal cord leads to inhibition of nociceptive neurons. Stimulation of the adrenoreceptors in the locus coeruleus results in sedation and anxiolysis and also terminates propagation of pain signals leading to analgesia.[10] Clonidine is a selective partial agonist for alpha-2- adrenoreceptors used intrathecally, with a well-established record of efficacy and safety.[11] Dexmedetomidine is a highly selective alpha-2-adrenoreceptor agonist with the alpha-2: alpha-1 binding ratio of 1620: 1 when compared with 220:1 for clonidine which is 8–10 times higher than that of clonidine.[12] The prolongation of spinal anesthesia after intravenous (IV) administration of dexmedetomidine and clonidine can be explained by the supraspinal effects of these drugs.[13,14] There are limited studies to show the dose equivalence of these two drugs; however, some studies showed that the dose of clonidine is 1.5–2 times higher than the dose of dexmedetomidine.[15,16] Therefore, we designed this prospective, randomized,  study to compare the efficacy of the IV infusion of clonidine 0.75  µg/kg vs. dexmedetomidine 0.75 Âµg/kg on spinal block characteristics as premedication to intrathecal 0.5% hyperbaric levobupivacaine in patients undergoing various lower limb and lower abdominal surgeries.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator 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

  • 1.All adult patients with ASA physical status I or II 2.either sex 3.18–60 years age 4.48–90 kg weight, 151–180 cm height and body mass index (BMI) between 20 and 35 kg/m2.

排除标准

  • We excluded the patients 1.with known hypersensitivity to LA, 2.infection at the injection site 3.history of bleeding disorders or on anticoagulants, 4.pregnancy, anatomical abnormality, and any comorbid condition such as preexisting peripheral neuropathy or neurological deficit, cerebrovascular accidents, endocrine, severe hepatic and renal dysfunction, chronic obstructive pulmonary disease, diabetes, sepsis, heart blocks, or dysrhythmias.
  • Patients on tranquilizers, hypnotics, sedatives, and other psychotropic drugs and drug addicts to opium or alcohol.

结局指标

主要结局

onset of sensory block

时间窗: Results will be assessed between 4 and 8 weeks

Time taken to achieve highest level

时间窗: Results will be assessed between 4 and 8 weeks

onset of motor blockade

时间窗: Results will be assessed between 4 and 8 weeks

Recovery of sensory block

时间窗: Results will be assessed between 4 and 8 weeks

Recovery of motor block

时间窗: Results will be assessed between 4 and 8 weeks

Duration of analgesia

时间窗: Results will be assessed between 4 and 8 weeks

次要结局

  • Heart rate(Mean arterial pressure)

研究者

发起方
velammal medical college and hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Renganathan Sockalingam

Velammal Hospital and Medical College

研究点 (1)

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