Effect of Sedatives on Regional Cerebral Oxygen Saturation

Not Applicable

Withdrawn

• Conditions: Cerebral Ischemia-Hypoxia
• Interventions: Drug: Midazolam; Drug: Dexmedetomidine

• Registration Number: NCT02966743
• Lead Sponsor: Gachon University Gil Medical Center

Brief Summary

Compare the changes of regional cerebral oxygen saturation during midazolam or dexmedetomidine sedation for spinal anesthesia in the elderly patients who undergoing femur surgery.

Detailed Description

Compare the changes of regional cerebral oxygen saturation during midazolam or dexmedetomidine administration (target bispectrl index 75-80) for spinal anesthesia in the elderly patients over 65 years who undergoing femur surgery.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-08
• Study First Submitted QC: 2016-11-15
• Study First Posted: 2016-11-17
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• patinets who undergoing femur surgery under spinal anesthesia

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Exclusion Criteria

• previous cerebrovascular disease, uncontrolled cardiovascular disorder, uncontrolled pulmonary disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
midazolam	Midazolam	administration of midazolam during spinal anesthesia for target bispectral index 75-80
dexmedetomidine	Dexmedetomidine	administration of dexmedeomidine during spinal anesthesia for target bispectral index 75-80

Primary Outcome Measures

Name	Time	Method
regional cerebral oxygen saturation	1 day

Trial Locations

Locations (1)

Gachon University Gil Hospital; 🇰🇷 Incheon, Korea, Republic of