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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Withdrawn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
Gachon University Gil Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cerebral Ischemia-Hypoxia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 8, 2016
Last Updated
February 14, 2019
Sponsor
Gachon University Gil Medical Center
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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Withdrawn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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