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Purpose of this study is to see if different levels of anesthesia have an effect on hearing spoken words without awareness of having heard them or anxiety after surgery.
Amnesia (lack of recall) is one of the most important goals of general anesthesia. Inadvertent free recall during a major surgical procedure is not only inhumane, but also predisposes the patient to morbidity such as post-traumatic stress disorder. Therefore, it is standard practice among anesthesiologists to inquire about free (explicit) recall during a post-anesthetic visit.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bispectral Index (BIS) 40 | Experimental | Target BIS 40 |
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| Bispectral Index (BIS) 60 | Experimental | Target BIS 60 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIS 40 | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To test the presence of implicit memory under two different planes of surgical general anesthesia in patients undergoing urologic (transurethral) or orthopedic (internal and external fixation) procedures | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the pre and postoperative anxiety levels as a marker of clinical significance of operational implicit memory function. | 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mehmet S. Ozcan, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
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| ID | Term |
|---|---|
| D056805 | Consciousness Monitors |
| C497852 | 61-bis(1-adamantylcarbamoyl)-1,2-methano(60)fullerene |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| BIS 60 | Combination Product | 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. |
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