Comparison of Preemptive Analgesic Effects of Dexketoprofen Versus Dexmedetomidine on Abdominal Hysterectomy Patients
NCT ID: NCT02092012
Last Updated: 2014-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2014-03-31
2014-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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dexketoprofen trometamol
ıv 50 mg dexketoprofen trometamol after anesthesia induction
dexketoprofen trometamol
ıv 50 mg dexketoprofen trometamol after anaesthesia induction
dexmedetomidine
ıv 1 mcg/kg dexmedetomidine after anaesthesia induction
Dexmedetomidine
ıv 1 mcg/kg dexmedetomidine after anaesthesia induction
Interventions
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dexketoprofen trometamol
ıv 50 mg dexketoprofen trometamol after anaesthesia induction
Dexmedetomidine
ıv 1 mcg/kg dexmedetomidine after anaesthesia induction
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled for elective abdominal hysterectomy
* No known allergies to drugs
* ASA I-II patients
Exclusion Criteria
* 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
18 Years
65 Years
FEMALE
No
Sponsors
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TC Erciyes University
OTHER
Responsible Party
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SELDA KAYAALTI, MD
resident
Principal Investigators
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selda kayaaltı, resident
Role: PRINCIPAL_INVESTIGATOR
erciyes univercity medicine faculty
Locations
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Erciyes Univercity Medicine Faculty
Kayseri, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2013/489
Identifier Type: -
Identifier Source: org_study_id
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