Depth of Anesthesia on Implicit Memory

NCT ID: NCT00584324

Last Updated: 2017-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2012-01-31

Brief Summary

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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

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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

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Anesthesia, General Memory

Keywords

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elective surgery general anesthesia implicit memory

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Bispectral Index (BIS) 40

Target BIS 40

Group Type EXPERIMENTAL

BIS 40

Intervention Type COMBINATION_PRODUCT

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 list of spoken words) via headphones under general anesthesia during the surgical procedure.

BIS 60

Intervention Type COMBINATION_PRODUCT

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 list of spoken words) via headphones under general anesthesia during the surgical procedure.

Bispectral Index (BIS) 60

Target BIS 60

Group Type EXPERIMENTAL

BIS 40

Intervention Type COMBINATION_PRODUCT

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 list of spoken words) via headphones under general anesthesia during the surgical procedure.

BIS 60

Intervention Type COMBINATION_PRODUCT

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 list of spoken words) via headphones under general anesthesia during the surgical procedure.

Interventions

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BIS 40

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 list of spoken words) via headphones under general anesthesia during the surgical procedure.

Intervention Type COMBINATION_PRODUCT

BIS 60

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 list of spoken words) via headphones under general anesthesia during the surgical procedure.

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Mini-mental state exam Spielberger State-Trait anxiety test Spoken word-stem completion test Bispectral Index Monitor Audio File Mini-mental state exam Spielberger State-Trait anxiety test Spoken word-stem completion test Bispectral Index Monitor Audio File

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mehmet S. Ozcan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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IRB No: 12634

Identifier Type: -

Identifier Source: org_study_id