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临床试验/NCT03463083
NCT03463083已完成不适用

Evaluation of the Analgesic Effect of Dexmedetomidine Versus Fentanyl as Adjuvants to Epidural Bupivacaine in Patients Undergoing Lumbar Spine Surgeries

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年3月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Post-operative analgesia duration assessment

研究概览

简要总结

To determine if the epidural route provide an acceptable analgesia in spine surgeries and avoided the need for excessive IV analgesics. Also to determine whatever dexmedetomidine or fentanyl is more better neuroaxial adjuvant regarding providing early onset and prolonged analgesia and stable cardiorespiratory parameters

详细描述

Relieving post-operative pain of spine surgeries has become an indispensable component in anesthesiology. Various methods have been tried for the management of post-operative pain in spine surgeries out of which regional techniques are becoming most promising. The quality of regional anesthesia has been reported to improve with the addition of opioids (such as morphine, fentanyl, and sufentanil) and other drugs (such as dexmedetomidine, clonidine, magnesium sulfate, neostigmine, ketamine, and midazolam), but no drug to inhibit nociception is without associated adverse effects . α2 adrenergic agonists have both analgesic and sedative properties when used as an adjuvant in regional anesthesia. Dexmedetomidine is an S-enantiomer of medetomidine with a higher specificity for α2-adrenoreceptor (α2 : α1, 1620 : 1) compared to clonidine (α2 : α1, 220 : 1). It was first introduced into practical use as intravenous sedative after the approval of U.S. Food and Drug Administration in 1999. Since then it has been investigated as the anxiolytic, sympatholytic, and analgesic properties related to α2-adrenoceptor binding, and it is now being used as a co-analgesic drug. As adjuvant, neuroaxial administration is the appropriate route to dexmedetomidine, because the analgesic effect of α2-agonists mostly occurs at spinal level, and dexmedetomidin's high lipophilicity facilitates rapid absorption into the cerebrospinal fluid and binding to the spinal cord α2-adrenoreceptor. regional-administeration of dexmedetomidine has been shown to exert potent antinociceptive effects in animals. To date, a few studies have reported on the effects of epidural dexmedetomidine combined with local anesthetics in humans. . Administration of an α2-agonist via an intrathecal or epidural route provides an analgesic effect in postoperative pain without severe sedation. This effect is due to the sparing of supraspinal CNS sites from excessive drug exposure, resulting in robust analgesia without heavy sedation . The adverse effects of dexmedetomidine include hypotension, hypertension, nausea, bradycardia, atrial fibrillation, and hypoxia. Fentanyl is one of the short-acting narcotic analgesics with potent morphine-like action . Neuroaxial administration of lipophilic opioids such as Fentanyl and sufentanyl tends to provide a rapid onset of analgesia. Their rapid clearance from cerebrospinal fluid may limit cephalic spread and the development of certain side effects such as delayed respiratory depression

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

盲法说明

An online randomization program (http://www.randomizer.org) will be used to generate random list and to allocate patients into the study groups. Random allocation numbers will be concealed in opaque closed envelops. The patient and investigator assessing study outcomes will all be blinded to the study groups allocation. The study drugs will be prepared by a separate investigator not involved in outcome assessment

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • All male patients between the age group of 18 and 65 years
  • Patients of American Society of Anaesthesiologists (ASA) class I and II.
  • Patients who will undergo lumbar spine surgeries (laminectomy ± discectomy for PIVD (Prolapse of intervertebral disc), will be enrolled for this study

排除标准

  • All Patients below the age of 18 years and above 65 years. Also All female patient are excluded from the study.
  • Other spine surgeries rather than laminectomy, also surgeries on more than two levels.
  • Patients with haematological disease, bleeding or coagulation test abnormalities, psychiatric diseases.
  • 4 .Patiensts with history of drug abuse, allergy to any study medication. . 4 .Patients with cervical and thoracic spine surgeries, tubercular spine , any permanent neurological disorders and vertebral deformeties such as scoliosis and spondylolisthesis.
  • Pregnant and lactating patients .
  • Withdrawal criteria :
  • Accidental Dural puncture.

研究组 & 干预措施

Bupivacaine dexmedetomidine group

Active Comparator

Group 1 (bupivacaine + dexmedetomidine (BD) group); will Receive an epidural study solution of 18 ml of 0.25% of bupivacaine hydrochloride plus 1 ml of dexmedetomidine (1 mcg/kg) plus 1 ml normal saline keeping the total volume of 20 ml in a syringe pump .

干预措施: Dexmedetomidine (Drug)

Bupivacaine dexmedetomidine group

Active Comparator

Group 1 (bupivacaine + dexmedetomidine (BD) group); will Receive an epidural study solution of 18 ml of 0.25% of bupivacaine hydrochloride plus 1 ml of dexmedetomidine (1 mcg/kg) plus 1 ml normal saline keeping the total volume of 20 ml in a syringe pump .

干预措施: Bupivacaine (Drug)

Bupivacaine fentanyl group

Active Comparator

Group 2 (bupivacaine + fentanyl (BF) group) ; will Receive an epidural study solution of 18 ml of 0.25% bupivacaine plus 2 ml fentanyl (1 mcg/kg) keeping the total volume of 20 ml in a syringe pump .

干预措施: Bupivacaine (Drug)

Bupivacaine fentanyl group

Active Comparator

Group 2 (bupivacaine + fentanyl (BF) group) ; will Receive an epidural study solution of 18 ml of 0.25% bupivacaine plus 2 ml fentanyl (1 mcg/kg) keeping the total volume of 20 ml in a syringe pump .

干预措施: Fentanyl (Drug)

结局指标

主要结局

Post-operative analgesia duration assessment

时间窗: 24 hours

The duration of effective analgesia; "it is the duration of complete pain relief (zero pain) and ends by the appearance of any pain (even VAS is of one)."

次要结局

  • Post-operative assessment of pain(24 hours)
  • Complete sensory and motor block(24 hours)
  • Sedation assessment(24 hours)
  • Heart rate monitoring(24 hours)
  • Mean arterial blood pressure(24 hours)
  • Vomiting assessment(24 hours)
  • Itching assessment(24 hours)
  • Urine retention assessment(24 hours)
  • Post-operative Neusea(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Abdalla

Assistant Professor of Anesthesia &I.C.U and Pain Clinic

Cairo University

研究点 (1)

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