Anesthesia Induction in Patients Undergoing Surgery for Cervical Myelopathy

Phase 4

• Conditions: Spinal Cord Diseases

• Registration Number: NCT01052337
• Lead Sponsor: University of Roma La Sapienza

Brief 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.

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.

Study Timeline

• Study Start: 2009-04
• Status Verified: 2009-12
• Study First Submitted: 2010-01-12
• Study First Submitted QC: 2010-01-19
• Last Update Submitted: 2010-01-19
• Study First Posted: 2010-01-20
• Last Update Posted: 2010-01-20
• Primary Completion: 2010-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 116

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
episode of severe arterial hypotension	at 0 minut, after 3 minuts, after 5 minuts

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Policlinico UMBERTO I; 🇮🇹 Rome, Italy