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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pain
• Intervention / Treatment: Drug: dexketoprofen trometamol; Drug: Dexmedetomidine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: selda kayaaltı, resident; Phone Number: +905558168918; Email: drselda@hotmail.com
• Study Contact Backup: Name: fatih ugur, assoc; Phone Number: +905359730073; Email: ugurf@erciyes.edu.tr

Study Locations

• Turkey
  • Kayseri, Turkey, 38039
    • Recruiting
    • Erciyes univercity medicine faculty
    • Contact: selda kayaaltı, resident; Phone Number: +905558168918; Email: drselda@hotmail.com
    • Contact: fatih ugur, assoc; Phone Number: +905359730073; Email: ugurf@erciyes.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: dexketoprofen trometamol; ıv 50 mg dexketoprofen trometamol after anesthesia induction	Drug: dexketoprofen trometamol; ıv 50 mg dexketoprofen trometamol after anaesthesia induction; Other Names: arveles
ACTIVE_COMPARATOR: dexmedetomidine; ıv 1 mcg/kg dexmedetomidine after anaesthesia induction	Drug: Dexmedetomidine; ıv 1 mcg/kg dexmedetomidine after anaesthesia induction; Other Names: precedex

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Principal Investigator: selda kayaaltı, resident, Erciyes univercity medicine faculty

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ANTICIPATED): June 1, 2014
• Study Completion (ANTICIPATED): July 1, 2014

Study Registration Dates

• First Submitted: March 18, 2014
• First Submitted That Met QC Criteria: March 18, 2014
• First Posted (ESTIMATE): March 19, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): March 21, 2014
• Last Update Submitted That Met QC Criteria: March 20, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: dexmedetomidine; postoperative pain; dexketoprofen trometamol
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine; Dexketoprofen trometamol
• Other Study ID Numbers: 2013/489