Clinical Trials Directory

Trials / Completed

CompletedNCT00584324

Depth of Anesthesia on Implicit Memory

The Effect of Depth of Anesthesia on Implicit Memory

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
70 (actual)
Sponsor
University of Oklahoma · Academic / Other
Sex
All
Age
55 Years – 90 Years
Healthy volunteers
Not accepted

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. 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).

Conditions

Interventions

TypeNameDescription
COMBINATION_PRODUCTBIS 40Mini-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.
COMBINATION_PRODUCTBIS 60Mini-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.

Timeline

Start date
2006-03-01
Primary completion
2012-01-01
Completion
2012-01-01
First posted
2008-01-02
Last updated
2026-04-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00584324. Inclusion in this directory is not an endorsement.