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Trial record 7 of 41 for:    Recruiting, Not yet recruiting, Available Studies | "Down Syndrome"

Comparison of Bispectral Index Values in Patients With and Without Down's Syndrome

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ClinicalTrials.gov Identifier: NCT02288702
Recruitment Status : Recruiting
First Posted : November 11, 2014
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Priti G. Dalal, Milton S. Hershey Medical Center

Brief Summary:
About 1 in every 700 babies born in the United States has Down's Syndrome (DS; Trisomy 21), 99% of whom have some degree of intellectual disability. Recent advances in medicine have resulted in a dramatically improved lifespan of about 25 to 60 years of age. Yet, there is limited data about anesthetic management in this increasing patient population. The bispectral index (BIS) monitor is a non-invasive monitoring device that reports a value between 0 and 100correlating to level of consciousness of an individual. A value of 0 indicates lack of brain activity while 100 indicates an awake/alert state. This monitor can be used to assess the depth of anesthesia. Patients with intellectual disability from congenital neurological diseases have lower BIS values compared to patients without any neurological impairment (Valkenburg 2009). The results may suggest that DS patients would require less anesthetic drugs compared to patients without any neurological impairment. To date, there are no studies in DS patients.

Condition or disease Intervention/treatment
Down Syndrome Device: monitoring BIS in both groups

Detailed Description:

Based on the Valkenburg group's study (2009), one might hypothesize that if the BIS value is fixed for all patients, then a patient with an intellectual disability such as a patient with DS would require less anesthetic drugs compared to a control patient without any neurological disability. However, if one is only using a clinical sedation scale, the DS patient may receive more anesthetic drugs in order to achieve the same level of clinical unconsciousness as a patient without DS.

This project seeks to elucidate the effect of anesthetic techniques and agents on patients with DS compared to those without DS and any intellectual disability. The goal of this project is to compare BIS values in patients with DS to those without DS undergoing a standardized general anesthetic technique. The investigators hypothesize that patients with DS would have lower (>25%) BIS values compared to those without DS.

Known potential sources of artifact signals that could change BIS values include electromyographic activity, electric devices, hypothermia, hypoglycemia, and the timing and type of anesthetics used (Duarte 2009, Dahaba 2005). These potential sources will be identified and reported during the study, and those patients will be excluded from the study


Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Comparison of Bispectral Index Values in Patients With and Without Down's Syndrome
Actual Study Start Date : October 2014
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome
U.S. FDA Resources

Group/Cohort Intervention/treatment
Normal
This is the group with no neurological problems or syndrome
Device: monitoring BIS in both groups
We will be monitoring BIS in both groups. A BIS monitor may be placed prior to induction or immmeditaely afterwards for monitoring BIS. All patients will receive general anesthesia. A standard inhalation induction agent such as sevoflurane and oxygen will be administered via face mask with or without an oral airway. An inhalation agent will be administered for the duration of the procedure. The MAC goal for inhalation agents will be 1. If the patient moves, the MAC goal will be increased to 1.5 and this change will be recorded.
Other Name: BIS
Down syndrome
This is the group with Down syndrome
Device: monitoring BIS in both groups
We will be monitoring BIS in both groups. A BIS monitor may be placed prior to induction or immmeditaely afterwards for monitoring BIS. All patients will receive general anesthesia. A standard inhalation induction agent such as sevoflurane and oxygen will be administered via face mask with or without an oral airway. An inhalation agent will be administered for the duration of the procedure. The MAC goal for inhalation agents will be 1. If the patient moves, the MAC goal will be increased to 1.5 and this change will be recorded.
Other Name: BIS



Primary Outcome Measures :
  1. measure BIS values in the normal patients and those with Down syndrome under anesthesia [ Time Frame: 2 years ]
    >25% lower BIS values in patients with DS compared to patients without DS



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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 2-17 years (inclusive) scheduled for tympanostomy on the 24-hr and 48-hr operating room (OR) schedules
Criteria

Inclusion Criteria:

  • • Patients with DS and those without DS receiving BIS monitoring

    • Children between the ages of 2 and 17 years old (inclusive)
    • Patients scheduled for unilateral or bilateral tympanostomy (ear tube placement) at Penn State Hershey Medical Center
    • Patients with American Society of Anesthesiologists (ASA) physical status I, II and III
    • Eligible for standard general anesthesia technique protocol as determined by anesthesia provider(s)

Exclusion Criteria:

  • Patients with congenital diseases/anomalies except Down's Syndrome
  • Patients with myotonic dystrophies or other neurodegenerative diseases
  • Patients with cerebrovascular accidents (strokes)
  • Patients not receiving BIS monitoring
  • Pregnant patients
  • Patients with allergic skin reactions to electrode patches
  • Patients 18 years of age and greater

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): NCT02288702


Contacts
Contact: Diane McCloskey 717-531-0003 ext 280359 dmccloskey@pennstathealth.psu.edu

Locations
United States, Pennsylvania
Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Diane McCloskey    717-531-0003 ext 280359    dmccloskey@pennstatehealth.psu.edu   
Sponsors and Collaborators
Milton S. Hershey Medical Center

Responsible Party: Priti G. Dalal, Associate Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02288702     History of Changes
Other Study ID Numbers: STUDY00000604
First Posted: November 11, 2014    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Down Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn