Phase 4
Completed N=39
The Synergistic Effect of Dexmedetomidine on Propofol for Sedation for Pediatric Endoscopy
Anesthesia
Source: ClinicalTrials.gov NCT02952222 ↗
Enrolled (actual)
39
Serious AEs
0.0%
Results posted
May 2024
Primary outcomePrimary: Propofol Requirements With Pre-treatment of Dexmedetomidine With Children Who do Not Receive Dexmedetomidine. — 0.4; 0.23 mg/kg/min
◆ Published Evidence
Established
21citations · ~4 / year
The synergistic effect of dexmedetomidine on propofol for paediatric deep sedation: A randomised trial.
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.
Linked Publications
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The synergistic effect of dexmedetomidine on propofol for paediatric deep sedation: A randomised trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Propofol Requirements With Pre-treatment of Dexmedetomidine With Children Who do Not Receive Dexmedetomidine. |
0.4; 0.23 | — |
| SECONDARY Frequency of Adverse Events and the Need for Airway Interventions |
0; 1 | — |
| SECONDARY Time Required to Achieve Sedation |
7.5; 7 | — |
| SECONDARY Time Required to Meet Discharge Criteria From Recovery Room |
63; 60 | — |
| SECONDARY Adverse Events |
0; 1 | — |
| SECONDARY Number of Unplanned Airway Interventions According to the World Society of Intravenous Anaesthesia (SIVA) Adverse Sedation Event Reporting Tool |
0; 1 | — |
| SECONDARY Emergence Delirium |
15; 18; 1; 1 | — |
| SECONDARY Time to BIS Score |
45; 50 | — |
| SECONDARY Duration of Sedation |
22; 33 | — |
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)
Data sourced from ClinicalTrials.gov (NCT02952222) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.