Comparison of Preemptive Analgesic Effects of Dexketoprofen Versus Dexmedetomidine on the Patients That is Undergoing Abdominal Hysterectomy
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
- 否
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
ıv 50 mg dexketoprofen trometamol after anesthesia induction
干预措施: dexketoprofen trometamol (Drug)
dexmedetomidine
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
SELDA KAYAALTI, MD
resident
TC Erciyes University
