The Effect of Depth of Anesthesia on Implicit Memory
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Oklahoma
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 55 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Persons signing informed consent
- •Elective general surgery for orthopedics (external or internal fixation) or urologic (transurethral)
- •Native English speaking
Exclusion Criteria
- •Hearing impaired
- •History of cognitive dysfunction
- •Subjects requiring post-operative sedation for any indication
Arms & Interventions
Bispectral Index (BIS) 40
Target BIS 40
Intervention: BIS 40 (Combination Product)
Bispectral Index (BIS) 40
Target BIS 40
Intervention: BIS 60 (Combination Product)
Bispectral Index (BIS) 60
Target BIS 60
Intervention: BIS 40 (Combination Product)
Bispectral Index (BIS) 60
Target BIS 60
Intervention: BIS 60 (Combination Product)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- To compare the pre and postoperative anxiety levels as a marker of clinical significance of operational implicit memory function.(3)
