Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Endotracheal Intubation Using Bonfils Fibrescope Without Neuromuscular Blockade

This study has been completed.
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00620386
First received: February 8, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00620386     History of Changes
Other Study ID Numbers: 105
Study First Received: February 8, 2008
Last Updated: February 8, 2008
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 November 19, 2014