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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01979653

Enrollment

Registered

2013-11-08

Start date

2013-11-30

Completion date

Unknown

Last updated

2016-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation; Aged; Hemodynamics

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.

Interventions

DRUGdexmedetomidine alone or dexmedetomidine + midazolam

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
hemodynamic stability	4 hour	comparison of bradycardia incidence

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026