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Effect 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Withdrawn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
Konkuk University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Injuries

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 9, 2015
Last Updated
April 17, 2021
Sponsor
Konkuk University Medical Center
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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Withdrawn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

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Effect of Loading of Midazolam or Dexmedetomidine on Hemodynamics

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