Correlation BIS Scores Mentally Retarded Patients

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00468338
Study type	Observational
Source	Rutgers, The State University of New Jersey
Contact
Status	Completed
Phase	N/A
Start date	December 2006
Completion date	May 2008

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.