Effect of Loading of Midazolam or Dexmedetomidine on Hemodynamics

NCT02634021 | Withdrawn Phase 4

• 1 other identifier: KUH1160088
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Injuries

Outcome Measures

Primary Outcomes (1)

• change of heart rate

  from 1 minute before anesthesia to 1 hr after anesthesia

Secondary Outcomes (1)

• change of bispectral index

  from 1 minute before anesthesia to 1 hr after anesthesia

Study Arms (2)

dexmedetomidine group

ACTIVE COMPARATOR

dexmedetomidine 1 mcg/kg intravenous loading followed by dexmedetomidine continuous infusion at the rate of 0.5 mcg/kg/hr

Drug: dexmedetomidine group

midazolam group

EXPERIMENTAL

midazolam 0.1 mg/kg intravenous loading followed by dexmedetomidine continuous infusion at the rate of 0.5 mcg/kg/hr

Drug: midazolam group

Interventions

dexmedetomidine group DRUG

intravenous loading of dexmedetomidine for 1 mcg/kg

Also known as: dexmedetomidine

dexmedetomidine group

midazolam group DRUG

intravenous loading of midazolam for 0.1 mg/kg

Also known as: midazolam

midazolam group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who were planned to undergo knee arthroscopy under spinal anesthesia

You may not qualify if:

• age \< 20 years
• underlying heart, liver or kidney disease
• hypersensitivity to midazolam or dexmedetomidine

Sponsors & Collaborators

• Konkuk University Medical Center: lead

Study Sites (1)

Konkuk University Medical Center

Seoul, 143-729, South Korea

Location

MeSH Terms

Conditions

Knee Injuries

Interventions

Dexmedetomidine; Midazolam

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Seong-Hyop Kim, Professor

  Konkuk University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 17, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)