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Hemodynamic Responses to Tracheal Intubation Direct Laryngoscope and Videolaryngoscope in Elderly Patients

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ClinicalTrials.gov Identifier: NCT02816775
Recruitment Status : Completed
First Posted : June 29, 2016
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Ülkü Özgül, Inonu University

Brief 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.

Condition or disease Intervention/treatment Phase
Aged Patients Device: Macintosh Laryngoscope Device: McGRATH Videolaryngoscope Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Actual Study Start Date : June 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : November 2016

Arm Intervention/treatment
Active Comparator: Group Laryngoscope
Group Laryngoscope; intubation will be made by Macintosh laryngoscope
Device: Macintosh Laryngoscope
After induction of anesthesia, tracheal intubation will made by Macintosh Laryngoscope

Active Comparator: Group Videolaryngoscope
Group Videolaryngoscope; intubation will be made by McGRATH Videolaryngoscope
Device: McGRATH Videolaryngoscope
After induction of anesthesia, tracheal intubation will made by McGRATH Videolaryngoscope




Primary Outcome Measures :
  1. mean blood pressure [ Time Frame: Change from baseline mean blood pressure at 30 minutes ]

Secondary Outcome Measures :
  1. QT interval [ Time Frame: Change from baseline QT interval at 30 minutes ]
  2. heart rate [ Time Frame: Change from baseline heart rate at 30 minutes ]
  3. Number of participants with treatment-related adverse events as assessed by 4- point scale [ Time Frame: From extubation until postoperative 24 hours ]
    Sore throat and hoarseness is graded as: none, mild, moderate, severe



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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • scheduled for elective surgery under general anesthesia requiring tracheal intubation

Exclusion Criteria:

  • hypertension,
  • cardiopulmonary disease,
  • diabetes mellitus,
  • a predicted problematic airway,
  • morbid obesity,
  • the use of medications known to affect blood pressure and heart rate as β-adrenergic blockers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02816775


Sponsors and Collaborators
Inonu University
Investigators
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Study Director: Türkan Toğal, Prof. Inonu University Faculty of Medicine

Publications of Results:
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Responsible Party: Ülkü Özgül, Associate professor, Inonu University
ClinicalTrials.gov Identifier: NCT02816775     History of Changes
Other Study ID Numbers: Ulku2
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ülkü Özgül, Inonu University:
hemodynamics
QT interval