The Synergistic Effect of Dexmedetomidine on Propofol for Sedation for Pediatric Endoscopy

PHASE4CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

May 11, 2018

Primary Completion Date

September 11, 2019

Study Completion Date

September 12, 2019

Conditions
Anesthesia
Interventions
DRUG

Dexmedetomidine

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.

DRUG

Propofol (Group P)

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.

DRUG

Propofol (Group DP)

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.

Trial Locations (1)

02115

Boston Children's Hospital, Boston

All Listed Sponsors
lead

Keira Mason

OTHER

NCT02952222 - The Synergistic Effect of Dexmedetomidine on Propofol for Sedation for Pediatric Endoscopy | Biotech Hunter | Biotech Hunter