Awakening in Spine Surgery: A Comparison Between Clinical Signs and Bispectral Index
Condition: Spine Diseases
MeSH terms: Spinal Diseases
Study type: Interventional

Summary: 
      BIS is one of several equipments used to monitor depth of anesthesia.Some studies found BIS
      can reduce total propofol dose when being used with target controlled infusion (TCI).The
      objective is to compare awakening time after spine surgery between using clinical signs and
      bispectral index (BIS) guided target controlled infusion(TCI) of propofol in patients having
      neurophysiologic monitoring.
    

Detailed description: 
      34 patients undergoing spine surgery will be enrolled and randomly assigned into two groups.
      We exclude patients who age under 18 and over 80 years, preoperative hemodynamics
      instability, propofol allergy, receiving drugs interfered with EEG, liver disease, Body Mass
      Index (BMI) over 30 kg/m2. Before induction the patient will be given 0.9% Sodium Chloride
      (NaCl) or acetate Ringer solution 7 ml/kg. Standard monitorings are used to all patients.

      Control group will receive fentanyl 1 mcg/kg and then fentanyl infusion 1 mcg/kg/hr and
      propofol TCI target 3-7 mcg/ml until asleep and then atracurium 0.5 mg/kg was given to
      facilitate endotracheal intubation. The patients will be ventilated with air:oxygen 1:1 L.
      The TCI propofol will be adjusted by clinical monitoring. If the patient has minor movement,
      the propofol TCI will be increased incrementally to 0.5 mcg/ml higher level but if major
      movement occurs the dose will be increased to1.0 mcg/ml higher. When hypotension occurs, this
      will be treated by fluid loading 200 ml in 10 min if it is not improved, then ephedrine or
      norepinephrine will be given and the TCI dose will be decreased by 0.5 mcg/ml lower level but
      not lower than 3.0 mcg/ml. Hypertension will be treated by fentanyl bolus 0.5 mcg/kg and
      increasing TCI dose to 0.5 mcg/ml higher level but not more than 7 mcg/ml. If hypertension
      persist, the nicardipine or diltiazem will be given.

      Intervention group receives fentanyl 1 mcg/kg and then fentanyl infusion 1 mcg/kg/hr and
      propofol by TCI 3-7 mcg/ml until asleep and then atracurium 0.5 mg/kg was given to facilitate
      endotracheal intubation. The patients will be ventilated with air:oxygen 1:1 L. Propofol will
      be adjusted by BIS monitoring. If the movement occurs and BIS 40-60, fentanyl 0.5 mcg/kg will
      be given, BIS > 60, TCI dose will be increased 0.5 mcg/ml higher level until BIS 40-60. When
      hypotension occurs, if BIS 40-60, will be treated by load fluid 200 ml in 10 mins, then
      ephedrine or norepinephrine will be given, If BIS < 40 the TCI dose will decrease 0.5 mcg/ml
      but not lower than 3.0 mcg/ml. Hypertension occurs, if BIS > 60 will be treated by fentanyl
      bolus 0.5 mcg/kg and TCI dose will be increased 0.5 mcg/ml higher level but not more than 7
      mcg/ml if not improved, nicardipine or diltiazem will be given. if BIS 40-60, nicardipine or
      diltiazem will be given.

      This outcome measures are extubation time,total propofol dose.
    

Intervention name(s): bispectral index; Target controlled infusion of propofol; Fentanyl; Atracurium
Intervention type(s): Device; Drug; Drug; Drug
Intervention description(s): Bispectral index (BIS) is one of several technologies used to monitor depth of anesthesia.; TCI propofol (3-7 mcg/dL, Schnider model) is used for total intravenous anesthesia in both groups; Fentanyl 1-2 mcg/kg iv for induction and then 0.5-1.0 mcg/kg/hr infusion is used for analgesic.; Atracurium 0.6 mg/kg is used for endotracheal intubation
Other intervention name(s): TCI propofol; Tracrium
Intervention MeSH terms: Fentanyl; Propofol; Atracurium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Keywords: Awakening time; Bispectral index; clinical signs; neurophysiologic monitoring; spine surgery