Effect of Loading of Midazolam or Dexmedetomidine on Hemodynamics

NCT ID: NCT02634021

Last Updated: 2021-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-07-31

Brief Summary

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

Detailed Description

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

Conditions

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Knee Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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dexmedetomidine group

dexmedetomidine 1 mcg/kg intravenous loading followed by dexmedetomidine continuous infusion at the rate of 0.5 mcg/kg/hr

Group Type ACTIVE_COMPARATOR

dexmedetomidine group

Intervention Type DRUG

intravenous loading of dexmedetomidine for 1 mcg/kg

midazolam group

midazolam 0.1 mg/kg intravenous loading followed by dexmedetomidine continuous infusion at the rate of 0.5 mcg/kg/hr

Group Type EXPERIMENTAL

midazolam group

Intervention Type DRUG

intravenous loading of midazolam for 0.1 mg/kg

Interventions

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dexmedetomidine group

intravenous loading of dexmedetomidine for 1 mcg/kg

Intervention Type DRUG

midazolam group

intravenous loading of midazolam for 0.1 mg/kg

Intervention Type DRUG

Other Intervention Names

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dexmedetomidine midazolam

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Konkuk University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Seong-Hyop Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seong-Hyop Kim, Professor

Role: PRINCIPAL_INVESTIGATOR

Konkuk University Medical Center

Locations

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Konkuk University Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KUH1160088

Identifier Type: -

Identifier Source: org_study_id

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