drugset / Trial / NCT05081206

Comparison of the Manually Controlled Propofol Infusion and Target Controlled Infusion in Children

NCT05081206 ↗

Completed 61 enrolled University Children's Hospital
RandomizedParallel-groupSingle-blindOther

Summary

Patients 1 to 8 years of age, American Society of Anesthesiologist score 1 and 2, planned for elective, one day surgery: inguinal hernia repair, hydrocele surgery, testis retention surgery, varicocele and phimosis surgery, and parents or legal guardians will be asked to sign written informed consent for participation in the study. Exclusion criteria will be: confirmed propofol allergies, mitochondrial disease, disease of lipid and carbohydrate metabolism, neurological disorders, treated psychiatric comorbidities, hypertension. All participants will be randomly assigned to two groups: one in which manually controlled propofol infusion will be used (MC group) and the other with target controlled infusion (TC group). After anesthesia induction depth of anesthesia during surgery will be measured using bispectral index (BIS), continuously. As a part of routine monitoring noninvasive blood pressure monitoring will be measured, and recorded in three time points, as well as heart rate. Time will be measured from the moment when propofol infusion was stopped till tracheal extubating.

Timeline

Start
2021-10-18
Primary completion
2022-01-17
Completion
2022-01-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Propofol Small molecule 3 ug/kg —
Subject Propofol Small molecule 6 mg/kg —

Indications

No indication recorded.