Hemodynamic Responses to Tracheal Intubation Direct Laryngoscope and Videolaryngoscope in Elderly Patients
Hemodynamic Responses to Tracheal Intubation Direct Laryngoscope and Videolaryngoscope in Elderly Patients: A Randomized, Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group Laryngoscope
Group Laryngoscope; intubation will be made by 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
|
After induction of anesthesia, tracheal intubation will made by McGRATH Videolaryngoscope
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mean blood pressure
Time Frame: Change from baseline mean blood pressure at 30 minutes
|
The patient's blood pressure should be measured and recorded at 5-minute intervals during the first 30 minutes of the operation.
|
Change from baseline mean blood pressure at 30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
QT interval
Time Frame: Change from baseline QT interval at 30 minutes
|
The QT interval in the ECG recordings in the first 30 minutes will be evaluated.
|
Change from baseline QT interval at 30 minutes
|
|
heart rate
Time Frame: Change from baseline heart rate at 30 minutes
|
The patient's heart rate should be measured and recorded at 5-minute intervals during the first 30 minutes of the operation.
|
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
|
From extubation until postoperative 24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Türkan Toğal, Prof., İnönü University Faculty of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Ulku2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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