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Correlation BIS Scores Mentally Retarded Patients

NCT ID: NCT00468338

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mental Retardation

Keywords

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general anesthesia dental rehabilitation mental retardation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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BIS monitor used for all subjects

BIS monitor applied to all subjects

BIS monitor

Intervention Type DEVICE

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

Interventions

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BIS monitor

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rex Ponnudurai, MD

Role: PRINCIPAL_INVESTIGATOR

University of Medicine and Dentistry of New Jersey

Locations

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UMDNJ University Hospital

Newark, New Jersey, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16115989 (View on PubMed)

Other Identifiers

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0120060266

Identifier Type: -

Identifier Source: org_study_id