Expired Study
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Oklahoma City, Oklahoma 73104


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.


Study summary:

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).


Criteria:

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 is Available At:


Original ID:

IRB No: 12634


NCT ID:

NCT00584324


Secondary ID:


Study Acronym:


Brief Title:

Depth of Anesthesia on Implicit Memory


Official Title:

The Effect of Depth of Anesthesia on Implicit Memory


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

55 Years


Maximum Age:

90 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Oklahoma


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

70


Enrollment Type:

Actual


Overall Contact Information

Official Name:Mehmet S. Ozcan, MD
Principal Investigator
University of Oklahoma

Study Dates

Start Date:March 2006
Completion Date:January 2012
Completion Type:Actual
Primary Completion Date:January 2012
Primary Completion Type:Actual
Verification Date:December 2017
Last Changed Date:December 18, 2017
First Received Date:December 20, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:To compare the pre and postoperative anxiety levels as a marker of clinical significance of operational implicit memory function.
Time Frame:3
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Combination Product
Name:BIS 40
Description: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
Arm Name:Bispectral Index (BIS) 40
Other Name:Mini-mental state exam
Intervention Type:Combination Product
Name:BIS 60
Description: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
Arm Name:Bispectral Index (BIS) 40
Other Name:Mini-mental state exam

Study Arms

Study Arm Type:Experimental
Arm Name:Bispectral Index (BIS) 40
Description:Target BIS 40
Study Arm Type:Experimental
Arm Name:Bispectral Index (BIS) 60
Description:Target BIS 60

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Oklahoma

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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