The Synergistic Effect of Dexmedetomidine on Propofol for Sedation for Pediatric Endoscopy
Status: | Recruiting |
---|---|
Conditions: | Hospital |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 7 - 18 |
Updated: | 6/30/2018 |
Start Date: | May 11, 2018 |
End Date: | July 2020 |
Contact: | Erin Halpin, MSN |
Email: | erin.halpin@childrens.harvard.edu |
Phone: | 857-218-4585 |
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.
propofol with that of children who receive dexmedetomidine prior to propofol, for sedation
for upper and lower endoscopic procedures.
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.
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.
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)
We found this trial at
1
site
300 Longwood Ave
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 355-6000
Phone: 857-218-4585
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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