Clinical Trials/NCT01979653

NCT01979653

Withdrawn

Not Applicable

A Comparision of Midazolam-dexmedetomidine With Dexmedetomidine Alone for Hemodynamic Stability and Quality of Sedation in Elderly Patients Under Spinal Anesthesia

Severance Hospital1 site in 1 countryNovember 2013

ConditionsSedation; Aged; Hemodynamics

Interventionsdexmedetomidine alone or dexmedetomidine + midazolam

Drugsdexmedetomidine alone or dexmedetomidine + midazolam

Overview

Phase: Not Applicable
Intervention: dexmedetomidine alone or dexmedetomidine + midazolam
Conditions: Sedation; Aged; Hemodynamics
Sponsor: Severance Hospital
Locations: 1
Primary Endpoint: hemodynamic stability
Status: Withdrawn
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare midazolam-dexmedetomidine with dexmedetomidine alone for hemodynamic stability and quality of sedation in elderly patients under spinal anesthesia.

Registry

clinicaltrials.gov

Start Date

November 2013

End Date

November 2013

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Severance Hospital

Responsible Party

Principal Investigator

So Yeon Kim

Assistant professor

Severance Hospital

Eligibility Criteria

Inclusion Criteria

•aged ≥ 65 years
•ASA physical status class I-II
•the patients who want sedation during elective lower limb surgery under spinal anesthesia

Exclusion Criteria

•contraindication to spinal anesthesia
•neurologic or cognitive dysfunction
•severe cardiovascular or pulmonary disease
•refusal to participation

Arms & Interventions

dexmedetomidine alone

dexmedetomidine 0.5 mcg/kg for 10 min + normal saline (volume-matched) bolus + dexmedetomidine 0.2-0.4 mcg/kg/hr infusion

Intervention: dexmedetomidine alone or dexmedetomidine + midazolam

dexmedetomidine + midazolam

normal saline (volume-matched) for 10 min + midazolam 0.2 mg/kg bolus + dexmedetomidine 0.2-0.4 mcg/kg/hr infusion

Intervention: dexmedetomidine alone or dexmedetomidine + midazolam

Outcomes

Primary Outcomes

hemodynamic stability

Time Frame: 4 hour

comparison of bradycardia incidence

Secondary Outcomes

Modified Observer Assessment of Alertness/Sedation (MOAAS) scale(4 hour)

Study Sites (1)

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