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Sponsored by: |
University of Medicine and Dentistry New Jersey |
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Information provided by: | University of Medicine and Dentistry New Jersey |
ClinicalTrials.gov Identifier: | NCT00468338 |
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 | Intervention |
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Mental Retardation |
Device: BIS monitor |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Correlation Between the Severity of Mental Retardation and BIS in Mentally Retarded Patients Undergoing Dental Rehabilitation |
Enrollment: | 90 |
Study Start Date: | December 2006 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
The subject group have different degrees of mental retardation and are undergoing dental rehabilitation.
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Bis monitor used for all subjects |
Device: BIS monitor
BIS monitor measures the depth of anesthesia and was used in the entire group
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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.
Ages Eligible for Study: | 12 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New Jersey | |
UMDNJ University Hospital | |
Newark, New Jersey, United States, 07103 |
Principal Investigator: | Rex Ponnudurai, MD | University of Medicine and Dentistry New Jersey |
Responsible Party: | UMDNJ ( Rex Ponnudurai, MD ) |
Study ID Numbers: | 0120060266 |
Study First Received: | April 30, 2007 |
Last Updated: | June 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00468338 History of Changes |
Health Authority: | United States: Institutional Review Board |
general anesthesia dental rehabilitation mental retardation |
Mental Retardation Signs and Symptoms Mental Disorders Mental Disorders Diagnosed in Childhood |
Anesthetics Neurologic Manifestations Neurobehavioral Manifestations |
Mental Retardation Signs and Symptoms Mental Disorders Mental Disorders Diagnosed in Childhood |
Nervous System Diseases Neurologic Manifestations Neurobehavioral Manifestations |