Effect of Sedatives on Regional Cerebral Oxygen Saturation | NCT02966743

Studies
Effect of Sedatives on Regional Cerebral Oxygen Saturation

NCT02966743

Sponsor

Gachon University Gil Medical Center

Status

Withdrawn

Last Update Posted

Feb 15, 2019Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Cerebral Ischemia-Hypoxia

Interventions

Midazolam
Dexmedetomidine

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Oct 2017Estimated

Completion Date

Oct 2017Estimated

First Submitted Date

Nov 8, 2016

First Submission Date that Met QC Criteria

Nov 15, 2016

First Posted Date

Nov 17, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2019

Last Update Posted Date

Feb 15, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Youn Yi Jo, Assistant professor, Gachon University Gil Medical CenterPrincipal Investigator

Lead Sponsor

Gachon University Gil Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Compare the changes of regional cerebral oxygen saturation during midazolam or dexmedetomidine administration (target bispectrl index 75-80) for spinal anesthesia in the elderly patients over 65 years who undergoing femur surgery.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Midazolam	Drug	administration of midazolam during spinal anesthesia for target bispectral index 75-80	midazolam

Measure	Description	Time Frame
regional cerebral oxygen saturation		1 day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patinets who undergoing femur surgery under spinal anesthesia

Exclusion Criteria:

previous cerebrovascular disease, uncontrolled cardiovascular disorder, uncontrolled pulmonary disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Youn Yi Jo, MD	Gachon University Gil Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gachon University Gil Hospital		Incheon			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020925	Hypoxia-Ischemia, Brain

Ancestor Terms

ID	Term
D002545	Brain Ischemia
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008874	Midazolam
D020927	Dexmedetomidine

Ancestor Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided