Current Environment:

Summary

The primary aim of this study is to compare the propofol requirements of children who receive propofol with that of children who receive dexmedetomidine prior to propofol, for sedation for upper and lower endoscopic procedures.

Conditions

Anesthesia

Recruitment Status

Active, not recruiting

Detailed Description

Both propofol and dexmedetomidine may be used to achieve adequate sedation conditions. Propofol has been described to produce successful conditions for completion of the intended study in almost 99% of the patients. However, in a study that reviewed outcomes when using propofol for almost 50,000 pediatric procedures, propofol was associated with stridor, laryngospasm, airway obstruction, wheezing or central apnea at a rate of 1 in 65 sedations. The need for airway and ventilation interventions which include oral/nasal airway placement, positive pressure mask ventilation and tracheal intubation occurred at a rate of 1 in 70 sedations. Hemodynamic and respiratory fluctuations of a minimum of 30% fluctuations in heart rate, blood pressure or respiratory rate occurred at a rate of 1 in 165 sedations. Another recent study cited similar incidences of hemodynamic variability with propofol as well as inhalational anesthesia in the outpatient pediatric setting. Until 2015, dexmedetomidine had been one of the standard drugs administered for sedation in children who require radiologic diagnostic imaging studies (MRI, CT and Nuclear Medicine) in the Department of Radiology at BCH. Over 17,000 infants, children and developmentally compromised young adults had been sedated with dexmedetomidine in BCH without a cardiac or respiratory arrest, or a need to provide positive pressure assisted ventilation. This study will determine if administration of dexmedetomidine with propofol administration will result in lower doses of the latter, which may mean safer outcomes in sedation for upper and lower endoscopic procedures.

Eligibility Criteria

Inclusion Criteria:

Ages 7-18 years who are scheduled for upper or lower endoscopic procedures at Boston Children's Hospital and meets criteria to receive dexmedetomidine or propofol sedation for upper and lower endoscopic procedures
Provides written consent to participate in the research study
For females of childbearing age, pregnancy test is negative

Exclusion Criteria:

Do not meet established sedation criteria
Refuses administration of study medication prior to sedation
History of allergy, intolerance, or reaction to dexmedetomidine or propofol or hypersensitivity
Current, repaired or risk of Moya-Moya disease
Recent stroke (cerebrovascular accident) within past 6 months
Uncontrolled hypertension
Concomitant use of opioids, beta antagonist, alpha 2 agonist or calcium channel blocker
Egg, soy or lecithin allergy
BMI greater than 30 or weight above 110th percentile
Refuses insertion of intravenous catheter while awake
Currently receiving pharmacologic agents for hypertension or cardiac disease
Currently receiving or has received digoxin within the past 3 months
Active, uncontrolled gastroesophageal reflux - an aspiration risk
Current (or within past 3 months) history of apnea requiring an apnea monitor
Unstable cardiac status (life threatening arrhythmias, abnormal cardiac anatomy, significant cardiac dysfunction)
Craniofacial anomaly, which could make it difficult to effectively establish a mask airway for positive pressure ventilation if needed
Active, current respiratory issues that are different from the baseline status (pneumonia, exacerbation of asthma, bronchiolitis, respiratory syncytial virus)

Intervention

Intervention Type

Intervention Name

Drug

Dexmedetomidine

Drug

Propofol (Group P)

Drug

Propofol (Group DP)

Phase

Phase 4

Gender

All

Minimum Age

7 Years

Maximum Age

18 Years

Download Date

October 25, 2021

Principal Investigator

Keira Mason

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: