Comparison of the Manually Controlled Propofol Infusion and Target Controlled Infusion in Children
Condition: Propofol Anesthesia in Children
Study type: Interventional

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.
    

Detailed description: 
      Prospective, randomized controlled study will be done at the University Children's Clinic.
      For the study ethical board approval was requested. Pediatric patients, planned for elective,
      one day surgery, requiring intubation with signed informed consent will be randomly assigned
      to two groups First in which manually controlled propofol infusion will be used (MC group)
      and the other with target controlled infusion (TC group).

      All participants will be premedicated half an hour before anesthesia induction with midazolam
      orally in dose of 0.5mg/kg body weight. Intravenous cannula will be placed 20-30 minutes
      later, and participants will receive atropine in dose of 0,02mg/kg intravenously, and
      fentanyl 1mcg/kg intravenously. In the MC group participants will receive propofol bolus
      2.5-3 mg/kg, for anesthesia induction and anesthesia maintenance will be done according to
      the Mc Farlan scheme. In TC group Pedfusor model will be used, with target concentration for
      anesthesia induction of 4 mcg/kg body weight and anesthesia maintenance of 3 mcg/kg. In all
      participants remifentanil in dose of 0.4mcg/kg/min will be used as analgesic, and
      cisatracurium 0.15mg/kg was muscle relaxant, for anesthesia induction. At the end of surgery,
      before remifentanil infusion is stopped, all patients will receive 0.5 mg/kg of ketorolac. If
      BIS values are out of the40-60 range during anesthesia, in MC group infusion rate will be
      changed and in TC group set plasma concentration (Cp) will be corrected. In case of heart
      rate increase or decrease for more than 20% compared to initial values, speed of remifentanil
      infusion will be decreased or increased, respectively. All participants will have standard
      monitoring during anesthesia: percutaneous saturation, end tidal concentration of carbon
      dioxide measurement, three channel electrocardiography, noninvasive blood pressure
      monitoring, and continuous BIS measurement. Propofol infusion will be stopped 5 minutes
      before expected end of surgery, and remifentanil infusion will be stopped at the end of
      surgery. Time will be measured from the moment when propofol infusion was stopped till
      tracheal extubating.
    

Intervention name(s): Propofol infusion via manually controlled pump.; Propofol infusion via target controlled pump.
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive propofol bolus 2.5-3 mg/kg, for anesthesia induction and anesthesia maintenance was continued according to the Mc Farlan scheme, meaning continuous propofol infusion is used, with gradual reduction of the infusion speed in timely manner, depending on the duration of surgery: 15mg/kg/h...13mg/kg/h...11mg/kg/h...9mg/kg/h...6mg/kg/h.; Pedfusor model was used for delivering target controlled plasma concentration, with target concentration for anesthesia induction of 4 mcg/kg body weight and then 3 mcg/kg.
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other