Phase 3
N=28
Use of Dexmedetomidine to Reduce Emergence Delirium Incident in Children
Agitation · Anesthesia · Pediatrics
Bottom Line
View on ClinicalTrials.gov: NCT00857727 ↗Enrolled (actual)
28
Serious AEs
7.1%
Results posted
Nov 2018
Primary outcome: Primary: Number of Participants With Emergence Delirium — 1; 7; 13; 7 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dexmedetomidine (Drug); Saline (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- St. Luke's-Roosevelt Hospital Center
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Emergence Delirium |
1; 7; 13; 7 | — |
| SECONDARY Vital Signs (Heart Rate, Blood Pressure, Respiratory Rate and Pulse Oximetry) Will be Continuously Monitored in the PICU |
— | — |
| SECONDARY Weight |
21.8; 18.5 | — |
| SECONDARY Length of Anesthesia |
199; 215 | — |
| SECONDARY Length of Surgery |
58; 86 | — |
| SECONDARY Total Study Drug |
1.55; 1.43 | — |
| SECONDARY Total Sevoflurane |
3.67; 6.80 | — |
| SECONDARY Total Propofol |
2.11; 2.41 | — |
| SECONDARY Total Fentanyl |
2.33; 2.36 | — |
Summary
Emergence delirium (ED) from general anesthesia posts risk and harm to pediatric population undergo general anesthesia. The purpose of the study is to compare the use of dexmedetomidine versus placebo in reducing the incidence and severity of ED in a pediatric neurosurgical population.
Eligibility Criteria
Inclusion Criteria
- Children age 6 months through 17 years of age undergoing interventional neuroradiologic procedures at our hospital under general anesthesia
- Patients classify as an ASA (American Society of Anesthesiologists) I-III
- Have not received anesthetic for over 30 days from previous procedures
Exclusion Criteria
- Receiving digoxin therapy from the study
- Severe congestive heart failure or pulmonary hypertension requiring vasodilators
- Disease processes other than that associated with their intracranial pathology, such as hepatic or renal dysfunction
Data sourced from ClinicalTrials.gov (NCT00857727). 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.