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NCT02634021 Clinical Trial

Effect of Loading of Midazolam or Dexmedetomidine on Hemodynamics

Knee Injuries Clinical Trial

Official title:
Hemodynamic Change Between Loading of Dexmedetomidine or Midazolam as a Sedative Agents During Knee Arthroscopy

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02634021
Other study ID # KUH1160088
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date July 2015
Est. completion date July 2018

Study information
Verified date April 2021
Source Konkuk University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date July 2018
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• dexmedetomidine group
intravenous loading of dexmedetomidine for 1 mcg/kg
• midazolam group
intravenous loading of midazolam for 0.1 mg/kg

Locations
Country Name City State
Korea, Republic of Konkuk University Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary change of heart rate from 1 minute before anesthesia to 1 hr after anesthesia
Secondary change of bispectral index from 1 minute before anesthesia to 1 hr after anesthesia
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