Hemodynamic Responses to Tracheal Intubation Direct Laryngoscope and Videolaryngoscope in Elderly Patients
Condition: Aged Patients
Study type: Interventional

Summary: 
      The intubation response to airway manipulation during direct laryngoscopy can cause
      hypertension, dysrhythmias and increased intracranial and intraocular pressures. This intense
      physiological response is proven to be associated with adverse outcomes especially in elderly
      patients. Increased QT dispersion is associated with increased risk of ventricular
      arrhythmias, which may increase the risk of sudden death caused by life-threatening
      arrhythmias. McGrath Videolaryngoscope would generate a lesser haemodynamic response than the
      conventional method of direct laryngoscopy. The objective of this study was to compare the
      hemodynamic response and QT during following tracheal intubation, using videolaryngoscope or
      direct laryngoscope to intubation. The postoperative airway morbidities is the investigators
      secondary outcome.
    

Detailed description: 
      Ninety patients, aged over 65 years, scheduled for elective surgery under general anesthesia
      requiring tracheal induction will be included in this study.

      All patients will divided into two groups by a sealed envelope technique, Group Laryngoscope;
      n = 45 and Group Videolaryngoscope; n = 45 to receive tracheal intubation using either a
      Macintosh laryngoscope (Group L) or a McGRATH videolaryngoscope (Group V).

      Hemodynamic data will evaluated by an anesthesiologist who was blinded to the study group
      affiliations. Evaluation of ECG will performed by a cardiologist.

      None of the patients will premedicated with any drug. Standard monitors, including ECG (lead
      II), noninvasive systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial
      pressure (MAP) and peripheral oxygen saturation (SpO2) measurements will be and mallampati
      classification, thyromental distance and mouth opening will be evaluated. After
      preoxygenation, anesthesia will induced with propofol 1.5 mg/kg. After loss of consciousness,
      rocuronium 0.5 mg/kg will injected intravenously (IV). Two minutes after rocuronium
      administration, fentanyl 2.0 μg/kg was given to each patient, and intubation will attempted
      with the direct laryngoscopy or McGrath Videolaryngoscopy. Anesthesia will maintained with
      sevoflurane in a mixture of 50% oxygen in 50% nitrous oxide.

      The following parameters will measured by a blind observer: number of intubation trials,
      intubation time (from insertion of the intubation device into the mouth to capnographic
      confirmation), airway trauma (detection of blood drops in the mouth, lip or the tube after
      removal). SBP, DBP, MAP heart rate and electrocardiography (ECG) will recorded at the
      following time points: before induction of anesthesia (pre-induction, T0), before tracheal
      intubation (post-induction, T1), 1,3,5 min post-intubation (T2, T3, T4, respectively).

      A 12-lead surface ECG was obtained from each subject while placed in the supine position. The
      12-lead ECG was recorded at a standardized article speed of 50 mm/sec and 2.0 millivolt/cm.
      Measurement of QT interval duration will carried out manually using a caliper.

      Pharyngolaryngeal injury in all patients will assessed by asking about sore throat and
      hoarseness 24 h after the surgery using an 4-point scale: none, mild, moderate and severe.
    

Intervention name(s): Macintosh Laryngoscope; McGRATH Videolaryngoscope
Intervention type(s): Device; Device
Intervention description(s): After induction of anesthesia, tracheal intubation will made by Macintosh Laryngoscope; After induction of anesthesia, tracheal intubation will made by McGRATH Videolaryngoscope
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: hemodynamics; QT interval