NCT00700674

Brief Summary

To determine if the usage of EEG Entropy helps to reduces the incidence of POCD in elderly patients after general anesthesia.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

October 21, 2021

Status Verified

February 1, 2010

Enrollment Period

3.8 years

First QC Date

June 18, 2008

Last Update Submit

October 14, 2021

Conditions

Keywords

EEG entropyElderlyDecreasesPOCDUse of EEG entropyGeriatric

Study Arms (2)

1

Entropy group

2

Control

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

60 Elderly patient, ASA 1-2

You may qualify if:

  • ASA physical status I-II.
  • scheduled for retinal surgery expected to take 2-3 hours under general anesthesia.
  • orotracheal intubation.

You may not qualify if:

  • history of cardiac, pulmonary, liver or renal disease.
  • significant obesity (body mass index \>30.
  • Long-term user of central nervous system activator drugs, benzodiazepines and/or opiates.
  • dementia, brain atrophy and other neurological disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Khaled Eye Specialist hospital

Riyadh, 11462, Saudi Arabia

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Waleed Riad, MD,AB,SB

    King Khaled Eye Specialist Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2008

First Posted

June 19, 2008

Study Start

January 1, 2008

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

October 21, 2021

Record last verified: 2010-02

Locations