Anesthesia Induction in Patients Undergoing Surgery for Cervical Myelopathy

Spinal Cord Diseases Clinical Trial

— Blade runner  

Official title:

Anesthesia Induction With Propofol or Sevoflurane in Patients Undergoing Fiberoptic Intubation for Cervical Myelopathy: Effects on Heamodynamics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01052337
• Other study ID #: Blade-runner
• Status: Recruiting
• Phase: Phase 4
• First received: January 12, 2010
• Last updated: January 19, 2010
• Start date: April 2009

Study information

• Verified date: December 2009
• Source: University of Roma La Sapienza
• Contact: Federico F Bilotta
• Phone: +39 339 33 70 822
• Email: bilotta[@]tiscali.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Diseases

Intervention

Drug:
• anaesthetics: sevofluorane
0.5%of sevofluorane with air

Locations

Country	Name	City	State
Italy	Policlinico UMBERTO I	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	episode of severe arterial hypotension		at 0 minut, after 3 minuts, after 5 minuts	No
Secondary	the incidence and duration of apnoea and the incidence of induction complications such as laryngospasm, coughing and patient movement during fiberoptic intubation.		at 0 minuts , at 5 minuts	No