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Sponsored by: |
Tehran University of Medical Sciences |
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Information provided by: | Tehran University of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT00620386 |
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 |
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
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2: Active Comparator
Intubation with Macintosh laryngoscopy
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Device: Macintosh
Endotracheal intubation using Macintosh laryngoscopy
|
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.
Ages Eligible for Study: | 15 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Iran, Islamic Republic of | |
Sina Hospital | |
Tehran, Iran, Islamic Republic of |
Study Director: | Reza Shariat Moharari, MD | Tehran University of Medical Sciences |
Principal Investigator: | Eiman Rahimi, MD | Tehran University of Medical Sciences |
Study ID Numbers: | 105 |
Study First Received: | February 8, 2008 |
Last Updated: | February 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00620386 |
Health Authority: | Iran: Ministry of Health |
Intubating conditions Bonfils intubation fiberscope Macintosh laryngoscope neuromuscular blockade |