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Completed

NCT Number: NCT02150759

Dexmedetomidine-ketamine in Femur Proximal Fracture Patients

* Comparison study of analgesic effects for dexmedetomidine-fentanyl vs dexmedetomidine-ketamine * lateral position for spinal anesthesia in femur proximal fracture patients

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haeundae paik hospital, inje university

Busan, 612-896, South Korea

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dexmedetomidine

Drug

dexmedetomidine infusion during spinal anesthesia

Other names: Precedex

Fentanyl

Drug

add dexmedetomidine during position change

Other names: fentanyl citrate

ketamine

Drug

add dexmedetomidine during position change

Other names: ketamine HCl

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study title

Comparison Study of Analgesic Effects for Dexmedetomidine-fentanyl vs Dexmedetomidine-ketamine in Femur Proximal Fracture Patients

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 30, 2014
Registry last updated
Apr 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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