Effect of Loading of Midazolam or Dexmedetomidine on Hemo... | NCT02634021

Studies
Effect of Loading of Midazolam or Dexmedetomidine on Hemodynamics

NCT02634021

Sponsor

Konkuk University Medical Center

Status

Withdrawn

Last Update Posted

Apr 20, 2021Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Knee Injuries

Interventions

dexmedetomidine group
midazolam group

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

Apr 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The investigator had no more scientific interest about this issue.

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Jul 2018Estimated

Completion Date

Jul 2018Estimated

First Submitted Date

Dec 9, 2015

First Submission Date that Met QC Criteria

Dec 14, 2015

First Posted Date

Dec 17, 2015Estimated

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

Apr 17, 2021

Last Update Posted Date

Apr 20, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Loading dose of dexmedetomidine is related hemodynamic instability such as bradycardia and hypertension.

Detailed Description

The investigators hypothesized substitution of loading of dexmedetomidine for midazolam could reduce hemodynamic instability during spinal anesthesia for knee arthroscopy.

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

Phase 4

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
dexmedetomidine group	Active Comparator	dexmedetomidine 1 mcg/kg intravenous loading followed by dexmedetomidine continuous infusion at the rate of 0.5 mcg/kg/hr	Drug: dexmedetomidine group
midazolam group	Experimental	midazolam 0.1 mg/kg intravenous loading followed by dexmedetomidine continuous infusion at the rate of 0.5 mcg/kg/hr	Drug: midazolam group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dexmedetomidine group	Drug	intravenous loading of dexmedetomidine for 1 mcg/kg	dexmedetomidine group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of heart rate		from 1 minute before anesthesia to 1 hr after anesthesia

Secondary Outcomes

Measure	Description	Time Frame
change of bispectral index		from 1 minute before anesthesia to 1 hr after anesthesia

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who were planned to undergo knee arthroscopy under spinal anesthesia

Exclusion Criteria:

age < 20 years
underlying heart, liver or kidney disease
hypersensitivity to midazolam or dexmedetomidine

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Seong-Hyop Kim, Professor	Konkuk University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Konkuk University Medical Center		Seoul		143-729	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007718	Knee Injuries

Ancestor Terms

ID	Term
D007869	Leg Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine
D008874	Midazolam

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided