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

NCT ID: NCT02092012

Last Updated: 2014-03-21

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-07-31

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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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dexketoprofen trometamol

ıv 50 mg dexketoprofen trometamol after anesthesia induction

Group Type ACTIVE_COMPARATOR

dexketoprofen trometamol

Intervention Type DRUG

ıv 50 mg dexketoprofen trometamol after anaesthesia induction

dexmedetomidine

ıv 1 mcg/kg dexmedetomidine after anaesthesia induction

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

ıv 1 mcg/kg dexmedetomidine after anaesthesia induction

Interventions

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dexketoprofen trometamol

ıv 50 mg dexketoprofen trometamol after anaesthesia induction

Intervention Type DRUG

Dexmedetomidine

ıv 1 mcg/kg dexmedetomidine after anaesthesia induction

Intervention Type DRUG

Other Intervention Names

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arveles precedex

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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SELDA KAYAALTI, MD

resident

Responsibility Role PRINCIPAL_INVESTIGATOR

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)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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selda kayaaltı, resident

Role: CONTACT

+905558168918

fatih ugur, assoc

Role: CONTACT

+905359730073

Facility Contacts

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selda kayaaltı, resident

Role: primary

+905558168918

fatih ugur, assoc

Role: backup

+905359730073

Other Identifiers

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2013/489

Identifier Type: -

Identifier Source: org_study_id

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