NCT00584324

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 2, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

December 20, 2017

Status Verified

December 1, 2017

Enrollment Period

5.8 years

First QC Date

December 20, 2007

Last Update Submit

December 18, 2017

Conditions

Anesthesia, GeneralMemory

Keywords

elective surgerygeneral anesthesiaimplicit memory

Outcome Measures

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

    3 years

Secondary Outcomes (1)

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

    3

Study Arms (2)

Bispectral Index (BIS) 40

EXPERIMENTAL

Target BIS 40

Combination Product: BIS 40Combination Product: BIS 60

Bispectral Index (BIS) 60

EXPERIMENTAL

Target BIS 60

Combination Product: BIS 40Combination Product: BIS 60

Interventions

BIS 40COMBINATION_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.

Also known as: Mini-mental state exam, Spielberger State-Trait anxiety test, Spoken word-stem completion test, Bispectral Index Monitor, Audio File
Bispectral Index (BIS) 40Bispectral Index (BIS) 60
BIS 60COMBINATION_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.

Also known as: Mini-mental state exam, Spielberger State-Trait anxiety test, Spoken word-stem completion test, Bispectral Index Monitor, Audio File
Bispectral Index (BIS) 40Bispectral Index (BIS) 60

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persons signing informed consent
  • Elective general surgery for orthopedics (external or internal fixation) or urologic (transurethral)
  • Literate
  • Native English speaking

You may not qualify if:

  • Hearing impaired
  • History of cognitive dysfunction
  • Subjects requiring post-operative sedation for any indication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Interventions

Consciousness Monitors61-bis(1-adamantylcarbamoyl)-1,2-methano(60)fullerene

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Study Officials

  • Mehmet S. Ozcan, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2007

First Posted

January 2, 2008

Study Start

March 1, 2006

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

December 20, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)