Clinical trial NCT02952222: The Synergistic Effect of Dexmedetomidine on Propofol for Sedation for Pediatric Endoscopy
Official title: The Synergistic Effect of Dexmedetomidine on Propofol for Sedation for Pediatric Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 39
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 Boston Children's Hospital (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)

Primary outcomes:
measure: Propofol Requirements With Pre-treatment of Dexmedetomidine With Children Who do Not Receive Dexmedetomidine.
timeFrame: up to 3 hours
Secondary outcomes:
measure: Frequency of Adverse Events and the Need for Airway Interventions
timeFrame: 1 day
measure: Time Required to Achieve Sedation
timeFrame: up to 30 minutes
measure: Time Required to Meet Discharge Criteria From Recovery Room
timeFrame: up to 4 hours
measure: Adverse Events
timeFrame: 3 days
measure: Number of Unplanned Airway Interventions According to the World Society of Intravenous Anaesthesia (SIVA) Adverse Sedation Event Reporting Tool
timeFrame: up to 3 hours
measure: Emergence Delirium
timeFrame: up to 4 hours
measure: Time to BIS Score
timeFrame: up to 6 hours
measure: Duration of Sedation
timeFrame: up to 3 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Keira Mason, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mason KP, Park RS, Sullivan CA, Lukovits K, Halpin EM, Imbrescia ST, Cavanaugh D, Prescilla R, Fox VL. The synergistic effect of dexmedetomidine on propofol for paediatric deep sedation: A randomised trial. Eur J Anaesthesiol. 2021 May 1;38(5):541-547. doi: 10.1097/EJA.0000000000001350.