Endotracheal Intubation Using Bonfils Fibrescope Without Neuromuscular Blockade

NCT ID: NCT00620386

Last Updated: 2008-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2007-08-31

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.

Conditions

Endotracheal Intubation; Hemodynamics; Neuromuscular Blockade

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Intubation with Bonfils intubating fiberscope

Group Type: EXPERIMENTAL

Bonfils

Intervention Type: DEVICE

Endotracheal intubation using Bonfils Intubating Fiberscope

2

Intubation with Macintosh laryngoscopy

Group Type: ACTIVE_COMPARATOR

Macintosh

Intervention Type: DEVICE

Endotracheal intubation using Macintosh laryngoscopy

Interventions

Bonfils

Endotracheal intubation using Bonfils Intubating Fiberscope

Intervention Type: DEVICE

Macintosh

Endotracheal intubation using Macintosh laryngoscopy

Intervention Type: DEVICE

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Principal Investigators

Reza Shariat Moharari, MD

Role: STUDY_DIRECTOR

Tehran University of Medical Sciences

Eiman Rahimi, MD

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Locations

Sina Hospital

Tehran, Tehran Province, Iran

Countries

Iran

Other Identifiers

105

Identifier Type: -

Identifier Source: org_study_id