Effect of Sedatives on Regional Cerebral Oxygen Saturation (2)
Primary Purpose
Cerebral Ischemia-Hypoxia
Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Midazolam
Dexmedetomidine
Sponsored by
About this trial
This is an interventional other trial for Cerebral Ischemia-Hypoxia
Eligibility Criteria
Inclusion Criteria:
- patinets who undergoing femur surgery under spinal anesthesia
Exclusion Criteria:
- previous cerebrovascular disease, uncontrolled cardiovascular disorder, uncontrolled pulmonary disease
Sites / Locations
- Gachon University Gil Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
midazolam
dexmedetomidine
Arm Description
administration of midazolam during spinal anesthesia for target bispectral index 75-80
administration of dexmedeomidine during spinal anesthesia for target bispectral index 75-80
Outcomes
Primary Outcome Measures
regional cerebral oxygen saturation
Secondary Outcome Measures
Full Information
NCT ID
NCT02966743
First Posted
November 8, 2016
Last Updated
February 14, 2019
Sponsor
Gachon University Gil Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02966743
Brief Title
Effect of Sedatives on Regional Cerebral Oxygen Saturation
Acronym
2
Official Title
Effect of Medazolam or Dexmedetomidine on Regional Cerebral Oxygen Saturation During Spinal Anesthesia in the Elderly Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Withdrawn
Study Start Date
November 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Ischemia-Hypoxia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
midazolam
Arm Type
Experimental
Arm Description
administration of midazolam during spinal anesthesia for target bispectral index 75-80
Arm Title
dexmedetomidine
Arm Type
Active Comparator
Arm Description
administration of dexmedeomidine during spinal anesthesia for target bispectral index 75-80
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Mida
Intervention Description
administration of midazolam during spinal anesthesia for target bispectral index 75-80
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Dex
Intervention Description
administration of dexmedetomidine during spinal anesthesia for target bispectral index 75-80
Primary Outcome Measure Information:
Title
regional cerebral oxygen saturation
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patinets who undergoing femur surgery under spinal anesthesia
Exclusion Criteria:
previous cerebrovascular disease, uncontrolled cardiovascular disorder, uncontrolled pulmonary disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youn Yi Jo, MD
Organizational Affiliation
Gachon University Gil Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Gachon University Gil Hospital
City
Incheon
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Sedatives on Regional Cerebral Oxygen Saturation
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