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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 : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Priti G. Dalal, Milton S. Hershey Medical Center

Tracking Information
First Submitted Date November 5, 2014
First Posted Date November 11, 2014
Last Update Posted Date February 4, 2019
Actual Study Start Date October 2014
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 7, 2014)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02288702 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison of Bispectral Index Values in Patients With and Without Down's Syndrome
Official Title Comparison of Bispectral Index Values in Patients With and Without Down's Syndrome
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.
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
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Down Syndrome
Intervention 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
Study Groups/Cohorts
  • Normal
    This is the group with no neurological problems or syndrome
    Intervention: Device: monitoring BIS in both groups
  • Down syndrome
    This is the group with Down syndrome
    Intervention: Device: monitoring BIS in both groups
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 7, 2014)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Diane McCloskey 717-531-0003 ext 280359 dmccloskey@pennstathealth.psu.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02288702
Other Study ID Numbers STUDY00000604
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Priti G. Dalal, Milton S. Hershey Medical Center
Study Sponsor Milton S. Hershey Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Milton S. Hershey Medical Center
Verification Date February 2019