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Clinical Trials/NCT00584324
NCT00584324CompletedNot Applicable

The Effect of Depth of Anesthesia on Implicit Memory

University of Oklahoma1 site in 1 country70 target enrollmentStarted: March 1, 2006Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Experimental

Target BIS 40

Intervention: BIS 40 (Combination Product)

Bispectral Index (BIS) 40

Experimental

Target BIS 40

Intervention: BIS 60 (Combination Product)

Bispectral Index (BIS) 60

Experimental

Target BIS 60

Intervention: BIS 40 (Combination Product)

Bispectral Index (BIS) 60

Experimental

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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