Depth of Anesthesia on Implicit Memory

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00584324
First received: December 20, 2007
Last updated: February 1, 2012
Last verified: February 2012

December 20, 2007
February 1, 2012
March 2006
January 2012   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00584324 on ClinicalTrials.gov Archive Site
To compare the pre and postoperative anxiety levels as a marker of clinical significance of operational implicit memory function. [ Time Frame: 3 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Depth of Anesthesia on Implicit Memory
The Effect of Depth of Anesthesia on Implicit Memory

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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
  • Anesthesia, General
  • Memory
  • 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.
    Other Name: SPS test
  • 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 Name: BIS Monitor
  • Other: Audio File
    Playing an audio file (a list of spoken words) via headphones under general anesthesia during the surgical procedure.
  • Experimental: 1
    Target BIS 40
    Interventions:
    • 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
  • Experimental: 2
    Target BIS 60
    Interventions:
    • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
55 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00584324
IRB No: 12634
Yes
University of Oklahoma
University of Oklahoma
Not Provided
Principal Investigator: Mehmet S. Ozcan, MD University of Oklahoma
University of Oklahoma
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP