Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2006-03-31
2012-01-31
Brief Summary
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Detailed Description
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Free recall requires a functional long term memory. Historically, lack of free recall during general anesthesia has been regarded as complete absence of long term memory activity. However, recent evidence suggests that the relationship between general anesthesia and memory is more complex than previously thought.
Objectives of the proposed are twofold: (1) to test the presence of implicit memory under two different planes of surgical general anesthesia in elderly males (55-90 years old) during a uniform surgical procedure (urologic procedures via transurethral approach) (2) to compare the pre and postoperative anxiety levels as a marker of clinical significance of operational implicit memory function.
The study is divided into three phases: pre-operative, operative, and post-operative.
Pre-operative phase will consist of a cognitive function test (mini-mental state exam). This will be administered at the urology or pre-operative anesthesia clinic visit, after obtaining the informed consent of the patient.
Operative phase will start with a baseline anxiety test (Spielberger state-trait anxiety test) just before being taken to the operating room. This will be followed by playing an audio file (a list of spoken words) via headphones under general anesthesia during the surgical procedure.
Post-operative phase will have of a spoken word-stem completion test (just before discharge from the hospital) and a repeat of the anxiety test mentioned above (2 to 3 weeks post-operatively).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Bispectral Index (BIS) 40
Target BIS 40
BIS 40
Mini-mental state exam: For subjects \> 60, this exam will be administered pre-operatively.
Spielberger State-Trait anxiety test: Spielberger test just before being taken to the operating room.
Spoken word-stem completion test: After discharge from recovery but within 24 hrs. post surgery, this test along with the anxiety test will be administered.
Bispectral Index Monitor: The physiologic monitor is used intraoperatively to assess surgical anesthesia.
Audio File: Playing an audio file (a list of spoken words) via headphones under general anesthesia during the surgical procedure.
BIS 60
Mini-mental state exam: For subjects \> 60, this exam will be administered pre-operatively.
Spielberger State-Trait anxiety test: Spielberger test just before being taken to the operating room.
Spoken word-stem completion test: After discharge from recovery but within 24 hrs. post surgery, this test along with the anxiety test will be administered.
Bispectral Index Monitor: The physiologic monitor is used intraoperatively to assess surgical anesthesia.
Audio File: Playing an audio file (a list of spoken words) via headphones under general anesthesia during the surgical procedure.
Bispectral Index (BIS) 60
Target BIS 60
BIS 40
Mini-mental state exam: For subjects \> 60, this exam will be administered pre-operatively.
Spielberger State-Trait anxiety test: Spielberger test just before being taken to the operating room.
Spoken word-stem completion test: After discharge from recovery but within 24 hrs. post surgery, this test along with the anxiety test will be administered.
Bispectral Index Monitor: The physiologic monitor is used intraoperatively to assess surgical anesthesia.
Audio File: Playing an audio file (a list of spoken words) via headphones under general anesthesia during the surgical procedure.
BIS 60
Mini-mental state exam: For subjects \> 60, this exam will be administered pre-operatively.
Spielberger State-Trait anxiety test: Spielberger test just before being taken to the operating room.
Spoken word-stem completion test: After discharge from recovery but within 24 hrs. post surgery, this test along with the anxiety test will be administered.
Bispectral Index Monitor: The physiologic monitor is used intraoperatively to assess surgical anesthesia.
Audio File: Playing an audio file (a list of spoken words) via headphones under general anesthesia during the surgical procedure.
Interventions
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BIS 40
Mini-mental state exam: For subjects \> 60, this exam will be administered pre-operatively.
Spielberger State-Trait anxiety test: Spielberger test just before being taken to the operating room.
Spoken word-stem completion test: After discharge from recovery but within 24 hrs. post surgery, this test along with the anxiety test will be administered.
Bispectral Index Monitor: The physiologic monitor is used intraoperatively to assess surgical anesthesia.
Audio File: Playing an audio file (a list of spoken words) via headphones under general anesthesia during the surgical procedure.
BIS 60
Mini-mental state exam: For subjects \> 60, this exam will be administered pre-operatively.
Spielberger State-Trait anxiety test: Spielberger test just before being taken to the operating room.
Spoken word-stem completion test: After discharge from recovery but within 24 hrs. post surgery, this test along with the anxiety test will be administered.
Bispectral Index Monitor: The physiologic monitor is used intraoperatively to assess surgical anesthesia.
Audio File: Playing an audio file (a list of spoken words) via headphones under general anesthesia during the surgical procedure.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Elective general surgery for orthopedics (external or internal fixation) or urologic (transurethral)
* Literate
* Native English speaking
Exclusion Criteria
* History of cognitive dysfunction
* Subjects requiring post-operative sedation for any indication
55 Years
90 Years
ALL
No
Sponsors
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University of Oklahoma
OTHER
Responsible Party
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Principal Investigators
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Mehmet S. Ozcan, MD
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma
Locations
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Countries
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Other Identifiers
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IRB No: 12634
Identifier Type: -
Identifier Source: org_study_id