Endotracheal Intubation Using Bonfils Fibrescope Without Neuromuscular Blockade - Full Text View

Sponsored by:	Tehran University of Medical Sciences
Information provided by:	Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00620386

Purpose

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	Intervention	Phase
Endotracheal Intubation Hemodynamics Neuromuscular Blockade	Device: Bonfils Device: Macintosh	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparing Intubating Conditions and Hemodynamic Changes Between Macintosh Laryngoscopy and Bonfils Fibrescope During Endotracheal Intubation Without Neuromuscular Blockade

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:

intubating conditions [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

mean arterial pressure (MAP) [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
heart rate (HR) [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
Pulse Oxygen Saturation (SpO2) [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Enrollment:	80
Study Start Date:	October 2006
Study Completion Date:	August 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Intubation with Bonfils intubating fiberscope	Device: Bonfils Endotracheal intubation using Bonfils Intubating Fiberscope
2: Active Comparator Intubation with Macintosh laryngoscopy	Device: Macintosh Endotracheal intubation using Macintosh laryngoscopy

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

Ages Eligible for Study:	15 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620386

Locations

Iran, Islamic Republic of
Sina Hospital
Tehran, Iran, Islamic Republic of

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

Study Director:	Reza Shariat Moharari, MD	Tehran University of Medical Sciences
Principal Investigator:	Eiman Rahimi, MD	Tehran University of Medical Sciences

More Information

No publications provided

Study ID Numbers:	105
Study First Received:	February 8, 2008
Last Updated:	February 8, 2008
ClinicalTrials.gov Identifier:	NCT00620386 History of Changes
Health Authority:	Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:

Intubating conditions
Bonfils intubation fiberscope
Macintosh laryngoscope
neuromuscular blockade

ClinicalTrials.gov processed this record on September 04, 2009