At a glance
ClinicalIndex Comparison Record- ✓Age 7–18 years scheduled for upper or lower endoscopic procedures at Boston Children's Hospital and meeting sedation criteria
- ✓Negative pregnancy test for females of childbearing age
- ✕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
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Synergistic Effect of Dexmedetomidine on Propofol for Sedation for Pediatric Endoscopy
In Brief
A Phase 4 clinical trial evaluating Dexmedetomidine, Propofol (Group P), and 1 other intervention for Anesthesia. Completed, enrolled 39 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Patients in Group DP will receive 0.5 mcg/kg Dexmedetomidine (DEX) administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of Bispectral Index (BIS) 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure.
Patients in Group P will receive intravenous propofol in bolus increments (2.0 mg/kg bolus over one minute then 0.5 mg/kg bolus q 1 minute titrated to a BIS of 40-50). These patients will be maintained with a continuous intravenous infusion of propofol starting at 200 mcg/kg/min and will be titrated to an endpoint of maintaining a BIS level of 40-50.
Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure.