Depth of Anesthesia on Implicit Memory
The Effect of Depth of Anesthesia on Implicit Memory
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Persons signing informed consent
- Elective general surgery for orthopedics (external or internal fixation) or urologic (transurethral)
- Literate
- Native English speaking
Exclusion Criteria:
- Hearing impaired
- History of cognitive dysfunction
- Subjects requiring post-operative sedation for any indication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Bispectral Index (BIS) 40
Target 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.
Other Names:
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 Names:
|
|
Experimental: Bispectral Index (BIS) 60
Target 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 Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To compare the pre and postoperative anxiety levels as a marker of clinical significance of operational implicit memory function.
Time Frame: 3
|
3
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mehmet S. Ozcan, MD, University of Oklahoma
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12634NotACT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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