NCT02150759

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 29, 2019

Completed
Last Updated

April 29, 2019

Status Verified

April 1, 2019

Enrollment Period

3.5 years

First QC Date

May 23, 2014

Results QC Date

August 19, 2018

Last Update Submit

April 25, 2019

Conditions

Pain

Keywords

DexmedetomidineKetaminePain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Quality of Patient Positioning

    average 10-20 minutes during spinal anesthesia

Study Arms (2)

Dexmedetomidine-ketamine

EXPERIMENTAL

Dexmedetomidine-ketamine group

Drug: DexmedetomidineDrug: Ketamine

Dexmedetomidine-fentanyl

ACTIVE COMPARATOR

Dexmedetomidine-fentanyl group

Drug: DexmedetomidineDrug: Fentanyl

Interventions

DexmedetomidineDRUG

dexmedetomidine infusion during spinal anesthesia

Also known as: Precedex
Dexmedetomidine-fentanylDexmedetomidine-ketamine
FentanylDRUG

add dexmedetomidine during position change

Also known as: fentanyl citrate
Dexmedetomidine-fentanyl
KetamineDRUG

add dexmedetomidine during position change

Also known as: ketamine HCl
Dexmedetomidine-ketamine

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American society of anesthesiologists classification 1-3 patients
  • \>20 years old

You may not qualify if:

  • patients refuse
  • dementia patients, cooperation difficult patients
  • anaphylaxis of dexmedetomidine, ketamine, local anesthetics
  • heart problem (bradycardia, atrioventricular block)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haeundae paik hospital, inje university

Busan, 612-896, South Korea

Location

MeSH Terms

Conditions

Pain

Interventions

DexmedetomidineFentanylKetamine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperidinesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Ki Hwa Lee
Organization
Inje University, Haeundae paik hospital
tedy3333@naver.com
82-51-797-0421

Study Officials

  • Sang Eun Lee, MD

    Inje University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 23, 2014

First Posted

May 30, 2014

Study Start

May 1, 2014

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

April 29, 2019

Results First Posted

April 29, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)