Induction of Anesthesia With Sevoflurane Preserving Spontaneous Breathing: Cardiorespiratory Effects.
Condition: Anesthesia Intubation Complication; Cardiovascular Complication; Intubation
Study type: Interventional
Phase: Phase 4

Summary: 
      Airway management is of outmost importance in the perioperative period. One of the main
      questions while making a plan for airway management is whether spontaneous ventilation should
      be maintained or not. Induction of anesthesia with Sevoflurane is a conventional technique
      that preserves spontaneous ventilation. It is used especially in non-collaborating patients
      or when other pharmaceutical agents or sophisticated airway management equipment is out of
      reach.

      Inhalational induction of anesthesia with Sevoflurane is well studied. However, there are few
      studies investigating the effects of Sevoflurane on induction and intubating conditions, on
      cardiopulmonary physiology, on emergence conditions, when it is used as one and only agent to
      achieve induction of anesthesia, intubation and maintenance of anesthesia in adult patients.
      There is also no consensus on the appropriate duration of the inhalational induction or other
      criteria to guarantee successful intubation conditions, since most studies investigate
      Sevoflurane administration until induction of anesthesia and not until intubation.

      From all the above, it appears that there are a few gaps in the management of patients who
      are to be intubated with Sevoflurane only, without the use of any other anesthetic agents.
    

Detailed description: 
      Preoperatively, the study protocol-mandated baseline data will be recorded: gender, age, body
      weight, body mass index, body surface area, ASA-PS, type of surgery. The airway assessment
      will include Mallampati score, thyromental distance, cervical spine mobility, upper lip bite
      test, mouth opening, micrognathia, protruding incisors, beard, denture, snoring.

      Patients will be randomly allocated into one of two groups: the S group was to be intubated
      after inhalational anesthesia with Sevoflurane only and maintenance of anesthesia with
      Sevoflurane 1MAC. The P group will receive standard anesthesia induction with propofol
      1,5mg/Kg, fentanyl 2mcg/Kg, rocuronium 0,5mg/Kg, while anesthesia will be maintained by
      sevoflurane.

      Before induction of anesthesia, we will record baseline data including BIS, SpO2, heart rate,
      invasive blood pressure, cardiac output, stroke volume, stroke volume variation, respiratory
      rate, and arterial blood gas sample recordings.

      During induction of anesthesia, the following data will be recorded: BIS, SpO2, heart rate,
      invasive blood pressure, cardiac output, stroke volume, stroke volume variation, respiratory
      rate, recordings from arterial blood gas sample, induction to anesthesia conditions (limb
      movement, cough, salivation, laryngospasm, and apnea), respiratory rate, tidal volume, minute
      volume, end-tidal CO2, the concentration of sevoflurane (inhaled, exhaled), peak inspiratory
      pressure, mean inspiratory pressure, dynamic respiratory compliance. In the S group, these
      data will be recorded again five minutes after the induction to anesthesia commencement.

      During intubation, we will record BIS, SpO2, heart rate, blood pressure, cardiac output,
      stroke volume, stroke volume variation, intubating conditions (jaw relaxation, vocal cord
      position, vocal cord movement, limb movement, bucking), Cormack-Lehane grade, duration of
      intubation.

      After intubation we will register: BIS, SpO2, heart rate, invasive blood pressure, cardiac
      output, stroke volume, stroke volume variation, respiratory rate, recordings from arterial
      blood gas sample, respiratory rate, tidal volume, minute volume, end-tidal CO2, the
      concentration of sevoflurane (inhaled, exhaled), peak inspiratory pressure, mean inspiratory
      pressure, dynamic respiratory compliance, were recorded. Patients having abolished
      spontaneous breathing will be set on the IMV mode of ventilation receiving tidal volume
      8ml/Kg, 10 breaths/min, PEEP=5cmH2O, I: E=1:2, Plateau time 30%.

      Upon the end of the surgical stimuli the following parameters will be registered: BIS, blood
      pressure, heart rate, SpO2, stroke volume, stroke volume variation, cardiac output, etCO2,
      respiratory rate, sevoflurane concentration (exhaled, inhaled), peak inspiratory pressure,
      mean inspiratory pressure, dynamic compliance, time of establishing spontaneous breathing,
      time of extubation.

      BIS, blood pressure, heart rate, SpO2, stroke volume, stroke volume variation, cardiac
      output, etCO2, the respiratory rate will be recorded 5 and 10 minutes respectively
      post-extubation.
    

Intervention name(s): Sevoflurane inhalant product; Propofol Fresenius
Intervention type(s): Drug; Drug
Intervention description(s): Sevoflurane 8% / O2 100% with the vital capacity breathing method (vital capacity induction, VCI) will be used for induction to anesthesia and facilitate endotracheal intubation.; Propofol 1,5mg/Kg, supplemented by fentanyl 2mcg/Kg and rocuronium 0,5mg/Kg and O2 100% will be for induction to anesthesia and facilitate endotracheal intubation. .
Other intervention name(s): Sevoflurane; Propofol
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: inhalational; sevoflurane; cardiovascular; induction