Dexmedetomidine-ketamine in Femur Proximal Fracture Patients

NCT ID: NCT02150759

Last Updated: 2019-04-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-11-30

Brief Summary

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

Detailed Description

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* 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

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexmedetomidine-ketamine

Dexmedetomidine-ketamine group

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

dexmedetomidine infusion during spinal anesthesia

Ketamine

Intervention Type DRUG

add dexmedetomidine during position change

Dexmedetomidine-fentanyl

Dexmedetomidine-fentanyl group

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

dexmedetomidine infusion during spinal anesthesia

Fentanyl

Intervention Type DRUG

add dexmedetomidine during position change

Interventions

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Dexmedetomidine

dexmedetomidine infusion during spinal anesthesia

Intervention Type DRUG

Fentanyl

add dexmedetomidine during position change

Intervention Type DRUG

Ketamine

add dexmedetomidine during position change

Intervention Type DRUG

Other Intervention Names

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Precedex fentanyl citrate ketamine HCl

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inje University

OTHER

Sponsor Role lead

Responsible Party

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Ki Hwa Lee

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sang Eun Lee, MD

Role: STUDY_CHAIR

Inje University

Locations

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Haeundae paik hospital, inje university

Busan, , South Korea

Site Status

Countries

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South Korea

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2014-027

Identifier Type: -

Identifier Source: org_study_id

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