Endotracheal Intubation Using Bonfils Fibrescope Without Neuromuscular Blockade

Neuromuscular Blockade Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620386
• Other study ID #: 105
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 8, 2008
• Last updated: February 8, 2008
• Start date: October 2006
• Est. completion date: August 2007

Study information

• Verified date: February 2008
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endotracheal Intubation
• Hemodynamics
• Neuromuscular Blockade

Intervention

Device:
• Bonfils
Endotracheal intubation using Bonfils Intubating Fiberscope
• Macintosh
Endotracheal intubation using Macintosh laryngoscopy

Locations

Country	Name	City	State
Iran, Islamic Republic of	Sina Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intubating conditions		7 months	Yes
Secondary	mean arterial pressure (MAP)		7 months	Yes
Secondary	heart rate (HR)		7 months	Yes
Secondary	Pulse Oxygen Saturation (SpO2)		7 months	Yes