A Comparision of Midazolam-dexmedetomidine With Dexmedetomidine Alone for Hemodynamic Stability and Quality of Sedation in Elderly Patients Under Spinal Anesthesia
Not Applicable
Withdrawn
- Conditions
- Sedation; Aged; Hemodynamics
- Interventions
- Registration Number
- NCT01979653
- Lead Sponsor
- Severance Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- aged ≥ 65 years
- ASA physical status class I-II
- the patients who want sedation during elective lower limb surgery under spinal anesthesia
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Exclusion Criteria
- contraindication to spinal anesthesia
- neurologic or cognitive dysfunction
- severe cardiovascular or pulmonary disease
- refusal to participation
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description dexmedetomidine alone dexmedetomidine alone or dexmedetomidine + midazolam dexmedetomidine 0.5 mcg/kg for 10 min + normal saline (volume-matched) bolus + dexmedetomidine 0.2-0.4 mcg/kg/hr infusion dexmedetomidine + midazolam dexmedetomidine alone or dexmedetomidine + midazolam normal saline (volume-matched) for 10 min + midazolam 0.2 mg/kg bolus + dexmedetomidine 0.2-0.4 mcg/kg/hr infusion
- Primary Outcome Measures
Name Time Method hemodynamic stability 4 hour comparison of bradycardia incidence
- Secondary Outcome Measures
Name Time Method Modified Observer Assessment of Alertness/Sedation (MOAAS) scale 4 hour
Trial Locations
- Locations (1)
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
🇰🇷Seoul, Korea, Republic of