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Endotracheal Intubation Using Bonfils Fibrescope Without Neuromuscular Blockade

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00620386
Enrollment
80
Registered
2008-02-21
Start date
2006-10-31
Completion date
2007-08-31
Last updated
2008-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotracheal Intubation, Hemodynamics, Neuromuscular Blockade

Keywords

Intubating conditions, Bonfils intubation fiberscope, Macintosh laryngoscope, neuromuscular blockade

Brief summary

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

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.

Interventions

DEVICEBonfils

Endotracheal intubation using Bonfils Intubating Fiberscope

DEVICEMacintosh

Endotracheal intubation using Macintosh laryngoscopy

Sponsors

Tehran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
intubating conditions7 months

Secondary

MeasureTime frame
Pulse Oxygen Saturation (SpO2)7 months
mean arterial pressure (MAP)7 months
heart rate (HR)7 months

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026