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Completed

NCT Number: NCT00620386

Endotracheal Intubation Using Bonfils Fibrescope Without Neuromuscular Blockade

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.

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Key information

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Sina Hospital

Tehran, Tehran Province, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bonfils

Device

Endotracheal intubation using Bonfils Intubating Fiberscope

Macintosh

Device

Endotracheal intubation using Macintosh laryngoscopy

Primary outcomes

  1. intubating conditions

    Time frame: 7 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 21, 2008
Registry last updated
Feb 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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