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

NCT02288702 | Terminated

• 1 other identifier: STUDY00000604
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome

Outcome Measures

Primary Outcomes (1)

• measure BIS values in the normal patients and those with Down syndrome under anesthesia

  \>25% lower BIS values in patients with DS compared to patients without DS

  2 years

Study Arms (2)

Normal

This is the group with no neurological problems or syndrome

Device: monitoring BIS in both groups

Down syndrome

This is the group with Down syndrome

Device: monitoring BIS in both groups

Interventions

monitoring BIS in both groups DEVICE

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.

Also known as: BIS

Down syndrome; Normal

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 11, 2014
• Study Start: October 1, 2014
• Primary Completion: July 13, 2017
• Study Completion: July 13, 2017
• Last Updated: January 23, 2023

Record last verified: 2023-01

Locations

US (1)