Clinical trial NCT02150759
Conditions: Pain
Keywords: Dexmedetomidine Ketamine Pain
Sponsor: Inje University
Start date: 2014-05-01; Completion date: 2017-11-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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

Arms: arm 1: Dexmedetomidine-ketamine group arm 2: Dexmedetomidine-fentanyl group
Interventions: intervention 1: Dexmedetomidine intervention 2: Fentanyl intervention 3: Ketamine
Intervention descriptions: intervention 1: dexmedetomidine infusion during spinal anesthesia intervention 2: add dexmedetomidine during position change intervention 3: add dexmedetomidine during position change

Protocol documents:
Prot_SAP_000.pdf: 
ID:2014-027 
Dexmedetomidine-ketamine in Femur Proximal Fracture Patients 
NCT02150759 
04-24-2019 
This study was approved by the institutional review board of Inje University Haeundae Paik 
Hospital (129792-2014-027) and written informed consent was obtained from patients. This 
study was registered before patient enrollment began at ClinicalTrials.gov (NCT02150759; 
date of registration: December 23, 2013). 
We hypothesized that ketamine or fentanyl could be better analgesics to control movement 
evoked pain in elderly patients with proximal femur fracture who were undergoing DEX 
continuous infusion. 
We compared the analgesic effect of Dexmedetomidine (1mcg/kg)- fentanyl (1mcg/kg) 
combination vs dexmedetomidine (1mcg/kg) - ketamine (1mg/kg) combination. After 10 
minutes of drug infusion, patients are prepared for spinal anesthesia. Pain scale and quality of 
patient during lateral positioning for spinal anesthesia were measured three times (lateral 
position, chest-knee position, intrathecal local anesthetics injection) 
Pain score (0 = calm, 1 = facial grimacing, 2 = moaning, 3 = screaming, 4 = unable to 
proceed because of restlessness or agitation) of patient position maintained for spinal block 
was recorded. Quality score (0 = not satisfactory, 1 = satisfactory, 2 = good, and 3 = optimal) 
of patient position maintained for spinal block was recorded. Data are presented as the 
number of patients. 
Data were analyzed using Medcalc 14.12.0 (MedCalc Software bvba, Ostend, Belgium). 
Parametric variables were described as mean ± standard deviation (SD). Qualitative variables 
were described as number and as median (interquartile range). Student’s t-test, Fisher’s exact 
test, or Mann-Whitney U-test was used as appropriate to compare the two groups. P < 0.05 
was considered to indicate statistical significant. 
 
  
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