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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by University of Roma La Sapienza.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01052337
First received: January 12, 2010
Last updated: January 19, 2010
Last verified: December 2009
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01052337

Contacts
Contact: Federico F Bilotta +39 339 33 70 822 bilotta@tiscali.it

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

No publications provided

Responsible Party: Federico Bilotta, Policlinico Umberto I
ClinicalTrials.gov Identifier: NCT01052337     History of Changes
Other Study ID Numbers: Blade-runner
Study First Received: January 12, 2010
Last Updated: January 19, 2010
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Bone Marrow Diseases
Spinal Cord Diseases
Hematologic Diseases
Central Nervous System Diseases
Nervous System Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014