Comparison of Preemptive Analgesic Effects of Dexketoprofen Versus Dexmedetomidine on Abdominal Hysterectomy Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: dexketoprofen trometamol
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18- 65 year female Scheduled for elective abdominal hysterectomy No known allergies to drugs ASA I-II patients Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexketoprofen trometamol<br>ıv 50 mg dexketoprofen trometamol after anesthesia induction | Drug: dexketoprofen trometamol<br>* ıv 50 mg dexketoprofen trometamol after anaesthesia induction<br>* Other names: arveles;|
| Active Comparator: dexmedetomidine<br>ıv 1 mcg/kg dexmedetomidine after anaesthesia induction | Drug: Dexmedetomidine<br>* ıv 1 mcg/kg dexmedetomidine after anaesthesia induction<br>* Other names: precedex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale | Visual Analog Scale on rest and movement record | postoperative 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic consumption | morphine consumption with patient controlled analgesia record | postoperative 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative pain, dexketoprofen trometamol, dexmedetomidine