Dexmetomidine in Children Undergoing General Anaesthesia
Condition: Anesthesia
Study type: Interventional

Summary: 
      The effects of dexmedetomidine on the onset of both the general anaesthesia induction and the
      neuromuscular blockade in children of school age will be investigated. Ten minutes before the
      induction of general anaesthesia, the first group will receive continuous infusion of
      dexmedetomidine (DEX group), while the second group will receive normal saline (Placebo
      group).
    

Detailed description: 
      Children 4 to 12 years old, ASA I-II, scheduled for elective minor or medium procedure under
      general anaesthesia will be included in the study, after written informed concern from their
      parents has been obtained. Participants will be randomly allocated according to the type of
      the solution infused 10 minutes before the induction of general anaesthesia into one of the
      following two groups using the closed envelop method.

      DEX group: patients will receive 0.5μcg/kg IV bolus of dexmedetomidine in 10 min, right
      before the induction of general anaesthesia. The concentration of dexmedetomidine solution is
      0.2μcg/ml, (100μcg of dexmedetomidine are diluted in 50ml N/S 0.9%), which corresponds to
      volume (ml) calculated by the type: "body weight (Kg)/4 or body weight (Kg) X 0.25".

      Placebo group: patients will receive N/S 0.9% IV in 10 min, right before the induction of
      general anaesthesia. The volume infused (ml) is determined by the same type: "body weight
      (Kg)/4 or body weight (Kg) X 0.25".

      The above solutions will be prepared by the anaesthetist who will provide the anaesthesia and
      will not be known to the anaesthetist who will record the study's measurements.

      No premedication will be given. All children will receive the same anaesthesia induction
      scheme.

      Once the patients have entered the operating theater, standard monitoring will be applied
      (NIBP, ECG, SpO2) and an IV line will be inserted. Depth of anaesthesia and monitoring of
      neuromuscular blockade will be recorded by BIS and TOF, respectively. Afterwards continues
      infusion of dexmedetomidine or N/S 0.9% will be initiated, depending on the assigned group,
      for duration of 10 min.

      Right after the end of the infusion, we will proceed to the induction of anaesthesia with
      3mg/kg of propofol and 2μcg/kg of fentanyl and when BIS<60 will be achieved, rocuronium will
      be administered at a dose of 0.7 mg/kg . Right afterwards, neuromuscular blockade will be
      estimated using the TOF acceleromyography (4 supramaximal twitches, 0.5sec interval in 2sec,
      frequency 2Hz, intensity 50mA). TOF will be repeated every 15sec. At the same time,
      ventilation of the patient will be supported with a bag and mask (Ο2 100%). When TOF=0 will
      be achieved, the patient will be intubated. After intubation, anaesthesia will be maintained
      with sevoflurane 1 MAC in 50% O2/Air.

      The intubation conditions will be estimated using the Viby-Mogensen score (scale of 5
      parameters). Also, number of intubation attempts will be recorded.

      The study period is from "right before the start" of the dexmedetomidine or the N/S 0.9%
      infusion up to 5 min after the tracheal intubation. The following time points will be
      recorded:

      Start time of the IV infusion of dexmedetomidine or N/S 0.9% (tstart) End time of the IV
      infusion of dexmedetomidine or N/S 0.9% (tend) Time of propofol injection (tprop) Time of
      achieving BIS<60 (tBIS<60) Time from propofol injection to achieve BIS<60 (tprop - tBIS<60)
      in min Time of rocuronium injection (troc) Time of achieving TOF=0 (tTOF=0) Time from
      rocuronium injection to TOF=0 (troc - tTOF=0) in min Time that intubation performed
      (tintubation)

      Measurements Heart rate (HR), systolic arterial pressure (SAP), SpO2 and BIS will be recorded
      at the following time points: just before the start of infusion of dexmedetomidine or N/S
      0.9% (tbaseline) and afterwards every 3 min during the infusion, as well as at the particular
      time points tend, tprop, tBIS<60, troc, tTOF=0, tintubation and 5 min after the intubation.
      Viby-Mogensen score and number of intubation attempts will also be recorded.

      During the study period, any adverse effects or incidences like respiratory depression during
      the 10 min infusion of the study solutions, bradycardia (defined as >20% reduction of HR from
      the baseline values or as HR<60bpm), hypotension (defined as >20mmHg reduction of SAP from
      the baseline values), allergic reactions, bronchospasm and laryngospasm will be recorded. In
      case of bradycardia or hypotension, IV atropine 0.02μcg/kg or ephedrine 1-2μcg/kg will be
      administered, respectively. In case of persistent bradycardia despite the use of atropine,
      dexmedetomidine infusion will be stopped and the child will be excluded from the study.
    

Intervention name(s): Dexmedetomidine; 0.9% saline
Intervention type(s): Drug; Other
Intervention description(s): INFUSION BEFORE INDUCTION OF ANAESTHESIA; INFUSION BEFORE INDUCTION OF ANAESTHESIA
Other intervention name(s): Dexmed; normal saline
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: dexmedetomidine; propofol; rocuronium; TOF; children