NCT00468338

Brief Summary

The BIS monitor is a tool which assists anesthesiologists in monitoring the depth of anesthesia or level of anesthesia. The study doctors would like to see if it is useful tool for patients who are mentally challenged and require anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2006

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

December 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

November 1, 2016

Status Verified

April 1, 2015

Enrollment Period

1.4 years

First QC Date

April 30, 2007

Last Update Submit

October 28, 2016

Conditions

Mental Retardation

Keywords

general anesthesiadental rehabilitationmental retardation

Study Arms (1)

BIS monitor used for all subjects

BIS monitor applied to all subjects

Device: BIS monitor

Interventions

BIS monitorDEVICE

BIS monitor measures the depth of anesthesia and was used in the entire group

BIS monitor used for all subjects

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

mentally retarded persons ages 12 to 65 ubdergoing dental rehabilitation

You may qualify if:

  • mentally retarded persons ages 12 to 65 undergoing dental rehabilitation

You may not qualify if:

  • patients who are pregnant parents/and or legal guardians who do not wish to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMDNJ University Hospital

Newark, New Jersey, 07103, United States

Location

Related Publications (1)

  • Dahaba AA. Different conditions that could result in the bispectral index indicating an incorrect hypnotic state. Anesth Analg. 2005 Sep;101(3):765-773. doi: 10.1213/01.ane.0000167269.62966.af.

    PMID: 16115989BACKGROUND

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Rex Ponnudurai, MD

    University of Medicine and Dentistry of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 30, 2007

First Posted

May 2, 2007

Study Start

December 1, 2006

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

November 1, 2016

Record last verified: 2015-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)