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Dexmedetomidine-ketamine in Femur Proximal Fracture Patients

I

Inje University

Status

Completed

Conditions

Pain

Treatments

Drug: Fentanyl
Drug: Ketamine
Drug: Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT02150759
2014-027

Details and patient eligibility

About

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

Full 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

Enrollment

46 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

46 participants in 2 patient groups

Dexmedetomidine-ketamine
Experimental group
Description:
Dexmedetomidine-ketamine group
Treatment:
Drug: Dexmedetomidine
Drug: Ketamine
Dexmedetomidine-fentanyl
Active Comparator group
Description:
Dexmedetomidine-fentanyl group
Treatment:
Drug: Dexmedetomidine
Drug: Fentanyl

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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