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NCT02150759 Clinical Trial

Dexmedetomidine-ketamine in Femur Proximal Fracture Patients

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02150759
Other study ID # 2014-027
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2014
Est. completion date November 2017

Study information
Verified date April 2019
Source Inje University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

- Comparison study of analgesic effects for dexmedetomidine-fentanyl vs dexmedetomidine-ketamine

- lateral position for spinal anesthesia in femur proximal fracture patients

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

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date November 2017
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dexmedetomidine
dexmedetomidine infusion during spinal anesthesia
• Fentanyl
add dexmedetomidine during position change
• Ketamine
add dexmedetomidine during position change

Locations
Country Name City State
Korea, Republic of Haeundae paik hospital, inje university Busan

Sponsors (1)
Lead Sponsor Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
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. average 10-20 minutes
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. average 10-20 minutes during spinal anesthesia
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