ClinicalTrials.gov
ClinicalTrials.gov Menu

Correlation BIS Scores Mentally Retarded Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00468338
Recruitment Status : Completed
First Posted : May 2, 2007
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

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.

Condition or disease Intervention/treatment
Mental Retardation Device: BIS monitor

Detailed Description:
General endotracheal tube anesthesia (GETA) is administered for mentally retarded patients that need dental rehabilitation. GETA is done, in all patients, with routine monitoring of electrocardiography, blood pressure recording, pulse oximetry and end-tidal capnography. These measurements are also used indirectly to determine the depth of anesthesia and the anesthetic is titrated to prevent awareness during surgery and any subsequent recall (1). In addition, a recently introduced functional electroencephalography (EEG)-based awareness monitor directly analyzes the brain wave pattern during anesthetic delivery and aids the anesthesiologist in maintaining the ideal depth of anesthesia. The EEG based monitor serves to prevent awareness and recall due to light anesthesia or prolonged recovery following deep anesthesia (2). This instrument, named the Bispectral Index Scale (BIS) monitor, is non-invasive and is approved by the Food & Drug Administration. However, the BIS monitor is not being used routinely during the anesthetic management of mentally retarded patients due to a belief that such monitoring would be inaccurate in this cohort of patients (3). This assumption lacks scientific validation. Our trial will investigate the usefulness of BIS monitoring in mentally retarded patients and document any correlation between the severity of mental retardation and BIS scoring during various phases of anesthesia, such as awake status and sedation prior to anesthesia, induction and maintenance of anesthesia, and emergence and recovery from anesthesia. The anesthetic protocol will be standardized and the anesthetic management will not deviate from routine practice. The adjuvant therapies for infection prophylaxis and pain control will be administered in the usual fashion.

Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Correlation Between the Severity of Mental Retardation and BIS in Mentally Retarded Patients Undergoing Dental Rehabilitation
Study Start Date : December 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
BIS monitor used for all subjects
BIS monitor applied to all subjects
Device: BIS monitor
BIS monitor measures the depth of anesthesia and was used in the entire group




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
mentally retarded persons ages 12 to 65 ubdergoing dental rehabilitation
Criteria

Inclusion Criteria:

  • mentally retarded persons ages 12 to 65 undergoing dental rehabilitation

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00468338


Locations
United States, New Jersey
UMDNJ University Hospital
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Rex Ponnudurai, MD University of Medicine and Dentistry of New Jersey

Publications:
Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00468338     History of Changes
Other Study ID Numbers: 0120060266
First Posted: May 2, 2007    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: April 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rutgers, The State University of New Jersey:
general anesthesia
dental rehabilitation
mental retardation

Additional relevant MeSH terms:
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders