Clinical trial NCT00620386: Endotracheal Intubation Using Bonfils Fibrescope Without Neuromuscular Blockade
Official title: Comparing Intubating Conditions and Hemodynamic Changes Between Macintosh Laryngoscopy and Bonfils Fibrescope During Endotracheal Intubation Without Neuromuscular Blockade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Endotracheal Intubation
Hemodynamics
Neuromuscular Blockade
Keywords: Intubating conditions
Bonfils intubation fiberscope
Macintosh laryngoscope
neuromuscular blockade
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-02-21
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: intubating conditions
timeFrame: 7 months
Secondary outcomes:
measure: mean arterial pressure (MAP)
timeFrame: 7 months
measure: heart rate (HR)
timeFrame: 7 months
measure: Pulse Oxygen Saturation (SpO2)
timeFrame: 7 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Sina Hospital
Study officials:
affiliation: Tehran University of Medical Sciences
name: Reza Shariat Moharari, MD
role: STUDY_DIRECTOR
affiliation: Tehran University of Medical Sciences
name: Eiman Rahimi, MD
role: PRINCIPAL_INVESTIGATOR
References: