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临床试验/NCT02092012
NCT02092012Unknown4 期

Comparison of Preemptive Analgesic Effects of Dexketoprofen Versus Dexmedetomidine on the Patients That is Undergoing Abdominal Hysterectomy

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
60
试验地点
1
主要终点
Visual Analog Scale

研究概览

简要总结

The aim of this study is to investigate comparison of preemptive analgesic effects of dexketoprofen versus dexmedetomidine on the patients that is undergoing abdominal hysterectomy.

详细描述

Abdominal hysterectomy is associated with moderate to severe postoperative pain which has unfavorable effects on patient's recovery and procedure's outcome. Administration of opioid analgesics is routinely practiced but is limited with dose-related adverse effects.[1] Within this concept, combining an opioid with different analgesics acting by different mechanisms as multimodal analgesia is recommended for effective post-operative pain control Dexketoprofen trometamol is a newly developed, centrally acting NSAID with potency similar to that of μ-opioid agonists.[4] In a number of studies in different pain models, it has been proven to have a good analgesic efficacy and tolerability.

Dexmedetomidine is a highly selective α2 adrenoceptor agonist that provides sedation, analgesia, and sympatholysis. These characteristics make dexmedetomidine useful anesthetic adjunct during operation. Previous studies report that intravenous has a definitive role in postoperative analgesia through the reduction of opioid consumption The aim of this prospective randomized, double-blind study is to evaluate the analgesic efficacy and opioid sparing effects of preemptive single dose of dexketoprofen trometamol in comparison with dexmedetomidine in the patients abdominal hysterectomy , over a 24-hour (h) investigation period.

After institutional approval and informed consent had been obtained, 60 patients scheduled for abdominal hysterectomy randomly allocated into two equal groups. Patients received ıv dexketoprofen 50 mg (Group I), ıv dexmedetomidine 1mcg/kg (Group II) after anesthesia induction and 10 minutes (min) before surgical incision. Patient controlled analgesia was supplied postoperatively using morphine. Hemodynamics, visual analogue scale (VAS), sedation score, morphine consumption, and side effects were recorded every and at 2, 6, 12 and 24 h after surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • 18- 65 year female
  • Scheduled for elective abdominal hysterectomy
  • No known allergies to drugs
  • ASA I-II patients

排除标准

  • Pregnancy
  • Drug or alcohol abuse
  • History of allergic reaction to any of the study drugs
  • Ongoing opioid, and non-steroidal anti-inflammatory
  • Analgesic therapy
  • Cardiac, respiratory, hepatic and/or renal failure
  • History of peptic ulcer disease

研究组 & 干预措施

dexketoprofen trometamol

Active Comparator

ıv 50 mg dexketoprofen trometamol after anesthesia induction

干预措施: dexketoprofen trometamol (Drug)

dexmedetomidine

Active Comparator

ıv 1 mcg/kg dexmedetomidine after anaesthesia induction

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Visual Analog Scale

时间窗: postoperative 1 day

Visual Analog Scale on rest and movement record

次要结局

  • analgesic consumption(postoperative 1 day)

研究者

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

SELDA KAYAALTI, MD

resident

TC Erciyes University

研究点 (1)

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