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| Sponsored by: |
University of Oklahoma |
|---|---|
| Information provided by: | University of Oklahoma |
| ClinicalTrials.gov Identifier: | NCT00584324 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Anesthesia, General Memory |
Behavioral: Mini-mental state exam Behavioral: Spielberg's State-Trait anxiety test Behavioral: Spoken word-stem completion test Device: Bispectral Index Monitor Other: Audio File |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | The Effect of Depth of Anesthesia on Implicit Memory |
| Estimated Enrollment: | 70 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Target BIS 40
|
Behavioral: Mini-mental state exam
For subjects > 60, this exam will be administered pre-operatively.
Behavioral: Spielberg's State-Trait anxiety test
Operative phase of study: Spielberg test just before being taken to the operating room.
Behavioral: 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.
Device: Bispectral Index Monitor
The physiologic monitor is used intraoperatively to assess surgical anesthesia
Other: Audio File
Playing an audio file (a list of spoken words) via headphones under general anesthesia during the surgical procedure.
|
|
2: Experimental
Target BIS 60
|
Behavioral: Mini-mental state exam
For subjects > 60, this exam will be administered pre-operatively.
Behavioral: Spielberg's State-Trait anxiety test
Operative phase of study: Spielberg test just before being taken to the operating room.
Behavioral: 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.
Device: Bispectral Index Monitor
The physiologic monitor is used intraoperatively to assess surgical anesthesia
Other: Audio File
Playing an audio file (a list of spoken words) via headphones under general anesthesia during the surgical procedure.
|
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 (Spielberg's 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).
Eligibility| Ages Eligible for Study: | 55 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Mehmet S. Ozcan, MD | 405-271-4351 | msozcan@gmail.com |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Mehmet S Ozcan, MD 405-271-4351 mehmet-ozcan@ouhsc.edu | |
| Principal Investigator: | Mehmet S. Ozcan, MD | University of Oklahoma |
More Information
| Responsible Party: | The University of Oklahoma Health Sciences Center, Department of Anesthesiology ( Mehemet Ozcan, MD ) |
| Study ID Numbers: | IRB No: 12634 |
| Study First Received: | December 20, 2007 |
| Last Updated: | December 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00584324 |
| Health Authority: | United States: Institutional Review Board |
|
elective surgery general anesthesia implicit memory |
