NCT02092012

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

March 21, 2014

Status Verified

March 1, 2014

Enrollment Period

3 months

First QC Date

March 18, 2014

Last Update Submit

March 20, 2014

Conditions

Keywords

postoperative paindexketoprofen trometamoldexmedetomidine

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale

    Visual Analog Scale on rest and movement record

    postoperative 1 day

Secondary Outcomes (1)

  • analgesic consumption

    postoperative 1 day

Study Arms (2)

dexketoprofen trometamol

ACTIVE COMPARATOR

ıv 50 mg dexketoprofen trometamol after anesthesia induction

Drug: dexketoprofen trometamol

dexmedetomidine

ACTIVE COMPARATOR

ıv 1 mcg/kg dexmedetomidine after anaesthesia induction

Drug: Dexmedetomidine

Interventions

ıv 50 mg dexketoprofen trometamol after anaesthesia induction

Also known as: arveles
dexketoprofen trometamol

ıv 1 mcg/kg dexmedetomidine after anaesthesia induction

Also known as: precedex
dexmedetomidine

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • year female
  • Scheduled for elective abdominal hysterectomy
  • No known allergies to drugs
  • ASA I-II patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes Univercity Medicine Faculty

Kayseri, 38039, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

PainPain, Postoperative

Interventions

dexketoprofen trometamolDexmedetomidine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • selda kayaaltı, resident

    erciyes univercity medicine faculty

    PRINCIPAL INVESTIGATOR

Central Study Contacts

selda kayaaltı, resident

CONTACT

fatih ugur, assoc

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

March 18, 2014

First Posted

March 19, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

March 21, 2014

Record last verified: 2014-03

Locations