Back to resultsEffect of Loading of Midazolam or Dexmedetomidine on Hemodynamics
Primary Purpose
Knee Injuries
Status
Withdrawn
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
dexmedetomidine group
midazolam group
Sponsored by
About this trial
This is an interventional treatment trial for Knee Injuries
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
Sites / Locations
- Konkuk University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
dexmedetomidine group
midazolam group
Arm Description
dexmedetomidine 1 mcg/kg intravenous loading followed by dexmedetomidine continuous infusion at the rate of 0.5 mcg/kg/hr
midazolam 0.1 mg/kg intravenous loading followed by dexmedetomidine continuous infusion at the rate of 0.5 mcg/kg/hr
Outcomes
Primary Outcome Measures
change of heart rate
Secondary Outcome Measures
change of bispectral index
Full Information
NCT ID
NCT02634021
First Posted
December 9, 2015
Last Updated
April 17, 2021
Sponsor
Konkuk University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02634021
Brief Title
Effect of Loading of Midazolam or Dexmedetomidine on Hemodynamics
Official Title
Hemodynamic Change Between Loading of Dexmedetomidine or Midazolam as a Sedative Agents During Knee Arthroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
The investigator had no more scientific interest about this issue.
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konkuk University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dexmedetomidine group
Arm Type
Active Comparator
Arm Description
dexmedetomidine 1 mcg/kg intravenous loading followed by dexmedetomidine continuous infusion at the rate of 0.5 mcg/kg/hr
Arm Title
midazolam group
Arm Type
Experimental
Arm Description
midazolam 0.1 mg/kg intravenous loading followed by dexmedetomidine continuous infusion at the rate of 0.5 mcg/kg/hr
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine group
Other Intervention Name(s)
dexmedetomidine
Intervention Description
intravenous loading of dexmedetomidine for 1 mcg/kg
Intervention Type
Drug
Intervention Name(s)
midazolam group
Other Intervention Name(s)
midazolam
Intervention Description
intravenous loading of midazolam for 0.1 mg/kg
Primary Outcome Measure Information:
Title
change of heart rate
Time Frame
from 1 minute before anesthesia to 1 hr after anesthesia
Secondary Outcome Measure Information:
Title
change of bispectral index
Time Frame
from 1 minute before anesthesia to 1 hr after anesthesia
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong-Hyop Kim, Professor
Organizational Affiliation
Konkuk University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Loading of Midazolam or Dexmedetomidine on Hemodynamics
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