78
Participants
Start Date
March 1, 2023
Primary Completion Date
June 1, 2024
Study Completion Date
July 1, 2024
Dexmedetomidine
"Infusion syringes are supplied with a concentration of 0.25 mcg / mL (dexmedetomidine ) either 80 mcg / 20 mL, 200 mcg / 50 mL, or 400 mcg / 100 mL.~For example, it begins with an infusion of 4 ml over 10 minutes and then continues the infusion, depending on the weight of the child, at a rate of 1.6 ml/kg/hour.~All injections will be prepared randomly by a doctor who did not participate in the study, and then placed in unmarked infusion pumps, given to an anesthesiologist (more than 10 years experience in pediatric anesthesia) without knowledge of the infusion content. The randomization process is carried out via sealed envelope technique.~The injections in both groups will be stopped before the skin is closed. Both patients and anesthesiologists blinded the study drug (dexmedetomidine or placebo) by infusion of solution (dexmedetomidine or placebo). Depending on the size in ml, to ensure that there is no bias and blindness to the medical team about what the drug is."
Normal saline
"Normal saline (NS) for intravenous infusion is supplied in pre-filled syringes of 20 ml, 50 ml, and 100 ml. To maintain blinding in this study, NS is handled identically to the study drug, dexmedetomidine. A physician not involved in the study prepares all injections, randomly assigning either NS or dexmedetomidine using a sealed envelope technique. Prepared syringes are then placed in identical, unmarked infusion pumps.~Infusion Protocol:~Anesthesiologists, blinded to the infusion contents, administer the solutions according to the protocol:~For example,Initial Bolus: 4 ml infused over 10 minutes, Maintenance Infusion: Continued at a rate of 1.6 ml/kg/hour, adjusted to the individual patient's weight.~This process ensures both patient and anesthesiologist remain blinded to the treatment arm, minimizing potential bias throughout the study."
University Children's Hospital, Damascus
University Children's Hospital
OTHER
Damascus University
OTHER