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Completed

NCT Number: NCT00584324

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.

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Key information

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIS 40

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.

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

BIS 60

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.

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

Primary outcomes

  1. 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

  1. To compare the pre and postoperative anxiety levels as a marker of clinical significance of operational implicit memory function.

    Time frame: 3

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

The Effect of Depth of Anesthesia on Implicit Memory

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Jan 2, 2008
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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