NCT01979653

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
Last Updated

October 14, 2016

Status Verified

November 1, 2013

Enrollment Period

Same day

First QC Date

November 3, 2013

Last Update Submit

October 13, 2016

Conditions

Sedation; Aged; Hemodynamics

Outcome Measures

Primary Outcomes (1)

  • hemodynamic stability

    comparison of bradycardia incidence

    4 hour

Secondary Outcomes (1)

  • Modified Observer Assessment of Alertness/Sedation (MOAAS) scale

    4 hour

Study Arms (2)

dexmedetomidine alone

EXPERIMENTAL

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

Drug: dexmedetomidine alone or dexmedetomidine + midazolam

dexmedetomidine + midazolam

EXPERIMENTAL

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

Drug: dexmedetomidine alone or dexmedetomidine + midazolam

Interventions

dexmedetomidine alone or dexmedetomidine + midazolamDRUG
dexmedetomidine + midazolamdexmedetomidine alone

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Interventions

DexmedetomidineMidazolam

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 3, 2013

First Posted

November 8, 2013

Study Start

November 1, 2013

Primary Completion

November 1, 2013

Last Updated

October 14, 2016

Record last verified: 2013-11

Locations

KR(1)