Comparing Hemodynamic Changes for Intubation With Shikani Intubating Stylet and Macintosh Laryngoscope
Condition: Anesthesia
Intervention: Endotracheal Intubation
Intervention description: General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with Shikani optical stylet (SOS) (one size) or MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for male in both groups. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Comparison of hemodynamic; endotracheal intubation; changes induced by; performed; the aid of the SOS; as compared to the Macintosh Laryngoscope

Summary:

      Because of its simplicity of function and reliability, direct laryngoscopy it is routinely
      used for endotracheal intubation during general anesthesia. However, direct laryngoscopy is
      fraught with concerns for cardiovascular stimulation during induction of general anesthesia.
      This can be attributed to the placement of the laryngoscope blade into the vallecula and then
      applying force in an upward direction to expose the glottic opening. The average force
      necessary for visualization of the glottic opening is approximately 5.4kg. This can lead to
      significant pressor responses and tachycardia though stimuli to supraglottic region.

      An alternative airway management device is the Shikani optical stylet (SOS). It is an
      effective, safe and reusable intubation device that has been shown to be effective in cases
      of difficult intubation. It consists of a fiberoptic bundle within a J - shaped malleable
      stainless steel sheath. At the proximal end of the sheath is an eyepiece with an attachment
      to a light source. An adjustable "tube stop" firmly affixes the endotracheal tube to the
      stylet, and has a port to be able to deliver oxygen. (4) The operator inserts the tip of the
      stylet with the loaded endotracheal tube into the patient's oropharynx and under direct
      visualization through the eyepiece, is able to visualize the vocal cords. Because the end of
      the stylet is at the end of the endotracheal tube, it can be directly visualized to be
      entering trachea past the vocal cords.

      The investigators hypothesize that endotracheal intubation performed by the aid of SOS by
      minimizing oropharyngolaryngeal stimulation will result in fewer hemodynamic changes in
      patients with normal airways as compared with the MacIntosh laryngoscope.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 - 75 years, ASA I and II, normotensive, Mallampati class: I and II, thyromental
             distance > than 6.5 cm, interincisor distance > than 3 cm, BMI < 35 Kg/m2

        Exclusion Criteria:

          -  Exclusion criteria: pregnant patients, known or expected difficult airway,
             gastroesophageal reflux, esophageal pathology, pulmonary pathology, cardiovascular
             pathology.