NCT02966743

Brief Summary

Compare the changes of regional cerebral oxygen saturation during midazolam or dexmedetomidine sedation for spinal anesthesia in the elderly patients who undergoing femur surgery.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

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

November 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

11 months

First QC Date

November 8, 2016

Last Update Submit

February 14, 2019

Conditions

Cerebral Ischemia-Hypoxia

Outcome Measures

Primary Outcomes (1)

  • regional cerebral oxygen saturation

    1 day

Study Arms (2)

midazolam

EXPERIMENTAL

administration of midazolam during spinal anesthesia for target bispectral index 75-80

Drug: Midazolam

dexmedetomidine

ACTIVE COMPARATOR

administration of dexmedeomidine during spinal anesthesia for target bispectral index 75-80

Drug: Dexmedetomidine

Interventions

MidazolamDRUG

administration of midazolam during spinal anesthesia for target bispectral index 75-80

Also known as: Mida
midazolam
DexmedetomidineDRUG

administration of dexmedetomidine during spinal anesthesia for target bispectral index 75-80

Also known as: Dex
dexmedetomidine

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • patinets who undergoing femur surgery under spinal anesthesia

You may not qualify if:

  • previous cerebrovascular disease, uncontrolled cardiovascular disorder, uncontrolled pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Hospital

Incheon, South Korea

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Interventions

MidazolamDexmedetomidine

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Youn Yi Jo, MD

    Gachon University Gil Medical Center

    STUDY DIRECTOR
0

Study Design

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

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 17, 2016

Study Start

November 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

KR(1)