Endotracheal Intubation Using Bonfils Fibrescope Without Neuromuscular Blockade

Study Overview
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Brief Summary
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We studied intubating conditions and hemodynamic changes during endotracheal intubation employing either Bonfils intubating fiberscope or the conventional Macintosh laryngoscopy in 80 healthy patients candidates for elective surgery requiring endotracheal intubation. We omitted neuromuscular blocking drugs from the induction regimen.

Detailed Description
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BACKGROUND: Neuromuscular blocking drugs (NMBDs) are believed to be the dominating antigens causing bronchospasm and anaphylaxis during anaesthesia. Avoidance of these drugs, however, renders compromised intubating conditions and higher morbidity with conventional Macintosh laryngoscopy. Thus, we compared Macintosh laryngoscopy with Bonfils intubation fibrescope without administering NMBDs. METHODS: Eighty male and female patients scheduled for elective surgery, aged 15 to 60 years, ASA class II or I, non-obese, with lower risk for difficult intubation were enrolled in this study. They were randomly allocated into the Bonfils group or the Macintosh group (40 each). Following adequate hydration and preoxygenation, midazolam 0.05 mg kg-1 was administered, followed by alfentanil 20 µg kg-1, lidocaine 1.5 mg kg-1, and propofol 2 mg kg-1 intravenously. Tracheal intubation was then carried out using Bonfils intubation fibrescope (Bonfils group) or employing conventional Macintosh laryngoscopy (Macintosh group). The primary outcome measure was the intubating condition, with mean arterial blood pressure and heart rate as secondary outcomes.

Official Title
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Comparing Intubating Conditions and Hemodynamic Changes Between Macintosh Laryngoscopy and Bonfils Fibrescope During Endotracheal Intubation Without Neuromuscular Blockade

Conditions
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Endotracheal Intubation, Hemodynamics, Neuromuscular Blockade

Intervention / Treatment
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* Device: Bonfils
* Device: Macintosh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiology (ASA) physical status was class I or II body mass index (BMI) < 30 ability to assume the 'sniffing' position Exclusion Criteria: smokers drug users pregnant expected to present difficult intubation history of oesophageal reflux any systemic or airway disease known allergy to the protocol medications

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Intubation with Bonfils intubating fiberscope | Device: Bonfils<br>* Endotracheal intubation using Bonfils Intubating Fiberscope<br>|
| Active Comparator: 2<br>Intubation with Macintosh laryngoscopy | Device: Macintosh<br>* Endotracheal intubation using Macintosh laryngoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intubating conditions |  | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean arterial pressure (MAP) |  | 7 months | 
| heart rate (HR) |  | 7 months | 
| Pulse Oxygen Saturation (SpO2) |  | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intubating conditions, Bonfils intubation fiberscope, Macintosh laryngoscope, neuromuscular blockade