FindTrial
Sign In

Dexmedetomidine-ketamine in Femur Proximal Fracture Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02150759
Enrollment
46
Registered
2014-05-30
Start date
2014-05-31
Completion date
2017-11-30
Last updated
2019-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Dexmedetomidine, Ketamine, Pain

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

Interventions

DRUGDexmedetomidine

dexmedetomidine infusion during spinal anesthesia

DRUGFentanyl

add dexmedetomidine during position change

DRUGKetamine

add dexmedetomidine during position change

Sponsors

Inje University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Pain Score Using Five Scalesaverage 10-20 minutesWe 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

MeasureTime frameDescription
Quality of Patient Positioningaverage 10-20 minutes during spinal anesthesiaWe estimate quality of patient positioning (0=not satisfactory, 1=satisfactory, 2=good, 3=optimal) during spinal anesthesia between two groups.

Countries

South Korea

Participant flow

Recruitment details

from May 2014 to October 2016

Participants by arm

ArmCount
Dexmedetomidine-Ketamine
Dexmedetomidine-Ketamine combination
22
Dexmedetomidine-Fentanyl
Dexmedetomidine-Fentanyl combination
21
Total43

Baseline characteristics

CharacteristicDexmedetomidine-KetamineDexmedetomidine-FentanylTotal
Age, Continuous78.28 years
STANDARD_DEVIATION 6.47
79.57 years
STANDARD_DEVIATION 7.13
78.90 years
STANDARD_DEVIATION 6.68
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
22 Participants21 Participants43 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
South Korea
21 participants22 participants43 participants
Sex: Female, Male
Female
20 Participants14 Participants34 Participants
Sex: Female, Male
Male
2 Participants7 Participants9 Participants
weight52.22 kg
STANDARD_DEVIATION 8.67
55.79 kg
STANDARD_DEVIATION 8.15
53.96 kg
STANDARD_DEVIATION 8.51

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 221 / 21
other
Total, other adverse events
21 / 2220 / 21
serious
Total, serious adverse events
0 / 221 / 21

Outcome results

Primary

Pain Score Using Five Scales

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.

Time frame: average 10-20 minutes

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Dexmedetomidine-ketaminePain Score Using Five ScalesSpinal blodk12 Participants
Dexmedetomidine-ketaminePain Score Using Five ScalesHip flexion017 Participants
Dexmedetomidine-ketaminePain Score Using Five ScalesLateral position15 Participants
Dexmedetomidine-ketaminePain Score Using Five ScalesHip flexion13 Participants
Dexmedetomidine-ketaminePain Score Using Five ScalesSpinal blodk017 Participants
Dexmedetomidine-ketaminePain Score Using Five ScalesHip flexion21 Participants
Dexmedetomidine-ketaminePain Score Using Five ScalesLateral position22 Participants
Dexmedetomidine-ketaminePain Score Using Five ScalesHip flexion31 Participants
Dexmedetomidine-ketaminePain Score Using Five ScalesHip flexion40 Participants
Dexmedetomidine-ketaminePain Score Using Five ScalesSpinal blodk23 Participants
Dexmedetomidine-ketaminePain Score Using Five ScalesLateral position30 Participants
Dexmedetomidine-ketaminePain Score Using Five ScalesSpinal blodk30 Participants
Dexmedetomidine-ketaminePain Score Using Five ScalesLateral position015 Participants
Dexmedetomidine-ketaminePain Score Using Five ScalesSpinal blodk40 Participants
Dexmedetomidine-ketaminePain Score Using Five ScalesLateral position40 Participants
Dexmedetomidine-fentanylPain Score Using Five ScalesSpinal blodk40 Participants
Dexmedetomidine-fentanylPain Score Using Five ScalesSpinal blodk011 Participants
Dexmedetomidine-fentanylPain Score Using Five ScalesSpinal blodk18 Participants
Dexmedetomidine-fentanylPain Score Using Five ScalesLateral position00 Participants
Dexmedetomidine-fentanylPain Score Using Five ScalesLateral position10 Participants
Dexmedetomidine-fentanylPain Score Using Five ScalesLateral position25 Participants
Dexmedetomidine-fentanylPain Score Using Five ScalesLateral position316 Participants
Dexmedetomidine-fentanylPain Score Using Five ScalesLateral position40 Participants
Dexmedetomidine-fentanylPain Score Using Five ScalesHip flexion01 Participants
Dexmedetomidine-fentanylPain Score Using Five ScalesHip flexion10 Participants
Dexmedetomidine-fentanylPain Score Using Five ScalesHip flexion26 Participants
Dexmedetomidine-fentanylPain Score Using Five ScalesHip flexion314 Participants
Dexmedetomidine-fentanylPain Score Using Five ScalesSpinal blodk22 Participants
Dexmedetomidine-fentanylPain Score Using Five ScalesSpinal blodk30 Participants
Dexmedetomidine-fentanylPain Score Using Five ScalesHip flexion40 Participants
Secondary

Quality of Patient Positioning

We estimate quality of patient positioning (0=not satisfactory, 1=satisfactory, 2=good, 3=optimal) during spinal anesthesia between two groups.

Time frame: average 10-20 minutes during spinal anesthesia

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Dexmedetomidine-ketamineQuality of Patient PositioningHip flexion16 Participants
Dexmedetomidine-ketamineQuality of Patient PositioningLateral position29 Participants
Dexmedetomidine-ketamineQuality of Patient PositioningHip flexion25 Participants
Dexmedetomidine-ketamineQuality of Patient PositioningSpinal block26 Participants
Dexmedetomidine-ketamineQuality of Patient PositioningHip flexion38 Participants
Dexmedetomidine-ketamineQuality of Patient PositioningLateral position38 Participants
Dexmedetomidine-ketamineQuality of Patient PositioningSpinal block01 Participants
Dexmedetomidine-ketamineQuality of Patient PositioningLateral position13 Participants
Dexmedetomidine-ketamineQuality of Patient PositioningSpinal block17 Participants
Dexmedetomidine-ketamineQuality of Patient PositioningHip flexion03 Participants
Dexmedetomidine-ketamineQuality of Patient PositioningSpinal block38 Participants
Dexmedetomidine-ketamineQuality of Patient PositioningLateral position02 Participants
Dexmedetomidine-fentanylQuality of Patient PositioningSpinal block30 Participants
Dexmedetomidine-fentanylQuality of Patient PositioningLateral position03 Participants
Dexmedetomidine-fentanylQuality of Patient PositioningLateral position115 Participants
Dexmedetomidine-fentanylQuality of Patient PositioningLateral position23 Participants
Dexmedetomidine-fentanylQuality of Patient PositioningLateral position30 Participants
Dexmedetomidine-fentanylQuality of Patient PositioningHip flexion05 Participants
Dexmedetomidine-fentanylQuality of Patient PositioningHip flexion113 Participants
Dexmedetomidine-fentanylQuality of Patient PositioningHip flexion23 Participants
Dexmedetomidine-fentanylQuality of Patient PositioningHip flexion30 Participants
Dexmedetomidine-fentanylQuality of Patient PositioningSpinal block03 Participants
Dexmedetomidine-fentanylQuality of Patient PositioningSpinal block25 Participants
Dexmedetomidine-fentanylQuality of Patient PositioningSpinal block113 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026