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
|Condition or disease||Intervention/treatment||Phase|
|Aged Patients||Device: Macintosh Laryngoscope Device: McGRATH Videolaryngoscope||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Actual Study Start Date :||June 2016|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||November 2016|
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
- mean blood pressure [ Time Frame: Change from baseline mean blood pressure at 30 minutes ]
- QT interval [ Time Frame: Change from baseline QT interval at 30 minutes ]
- heart rate [ Time Frame: Change from baseline heart rate at 30 minutes ]
- 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
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
|Study Director:||Türkan Toğal, Prof.||Inonu University Faculty of Medicine|