Effect of Loading of Midazolam or Dexmedetomidine on Hemodynamics

April 17, 2021 updated by: Seong-Hyop Kim, Konkuk University Medical Center

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: dexmedetomidine group
dexmedetomidine 1 mcg/kg intravenous loading followed by dexmedetomidine continuous infusion at the rate of 0.5 mcg/kg/hr
Drug: dexmedetomidine group
intravenous loading of dexmedetomidine for 1 mcg/kg
Other Names:
  • dexmedetomidine
Experimental: midazolam group
midazolam 0.1 mg/kg intravenous loading followed by dexmedetomidine continuous infusion at the rate of 0.5 mcg/kg/hr
Drug: midazolam group
intravenous loading of midazolam for 0.1 mg/kg
Other Names:
  • midazolam

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konkuk University Medical Center

Investigators

  • Principal Investigator: Seong-Hyop Kim, Professor, Konkuk University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

December 9, 2015

First Submitted That Met QC Criteria

December 14, 2015

First Posted (Estimate)

December 17, 2015

Study Record Updates

Last Update Posted (Actual)

April 20, 2021

Last Update Submitted That Met QC Criteria

April 17, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH1160088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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