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

Yonsei University

Status: Withdrawn

Conditions: Sedation; Aged; Hemodynamics

Treatments: Drug: dexmedetomidine alone or dexmedetomidine + midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT01979653

4-2013-0615

Details and patient eligibility

About

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.

Sex: All

Ages: 65+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

dexmedetomidine alone

Experimental group

Description:

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

Treatment:

Drug: dexmedetomidine alone or dexmedetomidine + midazolam

dexmedetomidine + midazolam

Experimental group

Description:

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

Treatment:

Drug: dexmedetomidine alone or dexmedetomidine + midazolam