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Dexmedetomidine-ketamine in Femur Proximal Fracture Patients

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ClinicalTrials.gov Identifier: NCT02150759
Recruitment Status : Completed
First Posted : May 30, 2014
Results First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Ki Hwa Lee, Inje University

Tracking Information
First Submitted Date  ICMJE May 23, 2014
First Posted Date  ICMJE May 30, 2014
Results First Submitted Date  ICMJE August 19, 2018
Results First Posted Date  ICMJE April 29, 2019
Last Update Posted Date April 29, 2019
Study Start Date  ICMJE May 2014
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2014)
Pain Score Using Five Scales [ Time Frame: average 10-20 minutes ]
We want to compare pain score (five scales; 0=calm, 1=facial grimacing, 2=moaning, 3=screaming, 4=restlessness or agitation, unable to proceed) when patients are lateral position during spinal anesthesia.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2014)
Quality of Patient Positioning [ Time Frame: average 10-20 minutes during spinal anesthesia ]
We estimate quality of patient positioning (0=not satisfactory, 1=satisfactory, 2=good, 3=optimal) during spinal anesthesia between two groups.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexmedetomidine-ketamine in Femur Proximal Fracture Patients
Official Title  ICMJE Comparison Study of Analgesic Effects for Dexmedetomidine-fentanyl vs Dexmedetomidine-ketamine in Femur Proximal Fracture Patients
Brief Summary
  • Comparison study of analgesic effects for dexmedetomidine-fentanyl vs dexmedetomidine-ketamine
  • lateral position for spinal anesthesia in femur proximal fracture patients
Detailed Description
  • Dexmedetomidine (1mcg/kg)- fentanyl (1mcg/kg) vs dexmedetomidine (1mcg/kg) - ketamine (1mg/kg) 10 minutes loading.
  • After 10 minutes of drug infusion, patients are prepared for spinal anesthesia.
  • pain scale and quality of patient positioning are measured three times (lateral position, chest-knee position, intrathecal local anesthetics injection)
  • When patients have severe pain during intraoperative period, fentanyl 50 mcg will be intravenously inject.
  • Patients will be injected propofol 10mg when they have agitation signs during operation.
  • vital signs, bispectral index, korean version of mini mental status examination, verbal rating scale,fentany/propofol consumption, frequency of intrathecal injection
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Dexmedetomidine
    dexmedetomidine infusion during spinal anesthesia
    Other Name: Precedex
  • Drug: Fentanyl
    add dexmedetomidine during position change
    Other Name: fentanyl citrate
  • Drug: Ketamine
    add dexmedetomidine during position change
    Other Name: ketamine HCl
Study Arms  ICMJE
  • Experimental: Dexmedetomidine-ketamine
    Dexmedetomidine-ketamine group
    Interventions:
    • Drug: Dexmedetomidine
    • Drug: Ketamine
  • Active Comparator: Dexmedetomidine-fentanyl
    Dexmedetomidine-fentanyl group
    Interventions:
    • Drug: Dexmedetomidine
    • Drug: Fentanyl
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2014)
46
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • American society of anesthesiologists classification 1-3 patients
  • >20 years old

Exclusion Criteria:

  • patients refuse
  • dementia patients, cooperation difficult patients
  • anaphylaxis of dexmedetomidine, ketamine, local anesthetics
  • heart problem (bradycardia, atrioventricular block)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02150759
Other Study ID Numbers  ICMJE 2014-027
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ki Hwa Lee, Inje University
Study Sponsor  ICMJE Inje University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Sang Eun Lee, MD Inje University
PRS Account Inje University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP