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Anesthesia Induction in Patients Undergoing Surgery for Cervical Myelopathy (Blade runner)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by University of Roma La Sapienza.
Recruitment status was:  Recruiting
Information provided by:
University of Roma La Sapienza Identifier:
First received: January 12, 2010
Last updated: January 19, 2010
Last verified: December 2009
Aim of this trial is to compare propofol-based anaesthesia vs. sevoflurane-based anaesthesia induction in patients with cervical myelopathy receiving oral or nasal fiberoptic intubation.

Condition Intervention Phase
Spinal Cord Diseases
Drug: anaesthetics: sevofluorane
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anesthesia Induction With Propofol or Sevoflurane in Patients Undergoing Fiberoptic Intubation for Cervical Myelopathy: Effects on Heamodynamics

Resource links provided by NLM:

Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • episode of severe arterial hypotension [ Time Frame: at 0 minut, after 3 minuts, after 5 minuts ]

Secondary Outcome Measures:
  • the incidence and duration of apnoea and the incidence of induction complications such as laryngospasm, coughing and patient movement during fiberoptic intubation. [ Time Frame: at 0 minuts , at 5 minuts ]

Estimated Enrollment: 116
Study Start Date: April 2009
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: propofol Drug: anaesthetics: sevofluorane
0.5%of sevofluorane with air
Active Comparator: sevofluorane Drug: anaesthetics: sevofluorane
0.5%of sevofluorane with air

Detailed Description:

Background: Fiberoptic intubation is the preferred method of intubation in patients with acute symptoms or signs of cervical myelopathy. This approach minimizes cervical spine movements to prevent new neurologic deficits or further neurologic injury, and is the safer method to secure the airways in patients with foreseen difficult intubation. In these patients anaesthesia induction is aimed to prevent cervical spine movements and to maintain hemodynamic stability. The most commonly reported technique for anaesthesia induction in patients with cervical myelopathy is based on local anaesthesia and propofol administration. Aim of this trial is to compare propofol-based anaesthesia vs. sevoflurane-based anaesthesia induction in patients with cervical myelopathy receiving oral or nasal fiberoptic intubation.

Methods: This randomized controlled trial is designed to prove equivalence. A series of 116 patients aged between 18 and 75 years, with cervical myelopathy will be enrolled. In all patients topical anaesthesia will be accomplished before anaesthesia induction. Patients will be randomly assigned to one of two anaesthesia induction strategies (sevoflurane + O2 + air or propofol + O2 + air). When loss of consciousness occurs (indicated by Bispectral index values between 40 and 50), oral or nasal fiberoptic intubation will be performed. The hemodynamic effects of the anaesthesia induction strategies will be assessed measuring mean arterial pressure at 4 time points: before anaesthesia induction (T1: baseline), at the end of anaesthesia induction when an adequate sedation level, with Bispectral index values 40-50, is achieved (T2: sedation steady state); immediately after placement of endotracheal tube (T3: intubation); five minute after tracheal intubation (T4: post-intubation). Secondary end-points of the study include the incidence of apnoea during induction process, diagnosed as absence of carbon dioxide trace for more than 10 seconds, the incidence of induction complications, defined as presence of laryngospasm, coughing and patient movement, and intubation conditions, defined as cord opening.

Discussion: We present the development phase of this anaesthesiological trial. A total of 40 patients have been enrolled from April 2009.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient undergoing cervical spine surgery;
  • Male or female;
  • Aged 18-75 years.

Exclusion Criteria:

  • Severe cardiovascular pathology;
  • Liver disease;
  • Renal disease;
  • BMI >35;
  • Allergies to any anaesthetic drugs.
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Please refer to this study by its identifier: NCT01052337

Contact: Federico F Bilotta +39 339 33 70 822

Policlinico UMBERTO I Recruiting
Rome, Italy, 00100
Contact: Federico F Bilotta    +39 339 33 70 822   
Sponsors and Collaborators
University of Roma La Sapienza
  More Information

Responsible Party: Federico Bilotta, Policlinico Umberto I Identifier: NCT01052337     History of Changes
Other Study ID Numbers: Blade-runner
Study First Received: January 12, 2010
Last Updated: January 19, 2010

Additional relevant MeSH terms:
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General processed this record on May 25, 2017