Effect of Loading of Midazolam or Dexmedetomidine on Hemodynamics

Phase 4

Withdrawn

• Conditions: Knee Injuries
• Interventions: Drug: dexmedetomidine group; Drug: midazolam group

• Registration Number: NCT02634021
• Lead Sponsor: Konkuk University Medical Center

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-12-09
• Study First Submitted QC: 2015-12-14
• Study First Posted: 2015-12-17
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-17
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine group	dexmedetomidine group	dexmedetomidine 1 mcg/kg intravenous loading followed by dexmedetomidine continuous infusion at the rate of 0.5 mcg/kg/hr
midazolam group	midazolam group	midazolam 0.1 mg/kg intravenous loading followed by dexmedetomidine continuous infusion at the rate of 0.5 mcg/kg/hr

Primary Outcome Measures

Name	Time	Method
change of heart rate	from 1 minute before anesthesia to 1 hr after anesthesia

Secondary Outcome Measures

Name	Time	Method
change of bispectral index	from 1 minute before anesthesia to 1 hr after anesthesia

Trial Locations

Locations (1)

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of