Endotracheal Intubation Using Bonfils Fibrescope Without Neuromuscular Blockade

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00620386
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : February 21, 2008
Information provided by:
Tehran University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Endotracheal Intubation Hemodynamics Neuromuscular Blockade Device: Bonfils Device: Macintosh Phase 2 Phase 3

Detailed Description:


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.


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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing Intubating Conditions and Hemodynamic Changes Between Macintosh Laryngoscopy and Bonfils Fibrescope During Endotracheal Intubation Without Neuromuscular Blockade
Study Start Date : October 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : August 2007

Arm Intervention/treatment
Experimental: 1
Intubation with Bonfils intubating fiberscope
Device: Bonfils
Endotracheal intubation using Bonfils Intubating Fiberscope

Active Comparator: 2
Intubation with Macintosh laryngoscopy
Device: Macintosh
Endotracheal intubation using Macintosh laryngoscopy

Primary Outcome Measures :
  1. intubating conditions [ Time Frame: 7 months ]

Secondary Outcome Measures :
  1. mean arterial pressure (MAP) [ Time Frame: 7 months ]
  2. heart rate (HR) [ Time Frame: 7 months ]
  3. Pulse Oxygen Saturation (SpO2) [ Time Frame: 7 months ]

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00620386

Iran, Islamic Republic of
Sina Hospital
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Study Director: Reza Shariat Moharari, MD Tehran University of Medical Sciences
Principal Investigator: Eiman Rahimi, MD Tehran University of Medical Sciences Identifier: NCT00620386     History of Changes
Other Study ID Numbers: 105
First Posted: February 21, 2008    Key Record Dates
Last Update Posted: February 21, 2008
Last Verified: February 2008

Keywords provided by Tehran University of Medical Sciences:
Intubating conditions
Bonfils intubation fiberscope
Macintosh laryngoscope
neuromuscular blockade