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

Primary Purpose

Spinal Cord Diseases

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
anaesthetics: sevofluorane
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Policlinico UMBERTO IRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

propofol

sevofluorane

Arm Description

Outcomes

Primary Outcome Measures

episode of severe arterial hypotension

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.

Full Information

First Posted
January 12, 2010
Last Updated
January 19, 2010
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT01052337
Brief Title
Anesthesia Induction in Patients Undergoing Surgery for Cervical Myelopathy
Acronym
Blade runner
Official Title
Anesthesia Induction With Propofol or Sevoflurane in Patients Undergoing Fiberoptic Intubation for Cervical Myelopathy: Effects on Heamodynamics
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
propofol
Arm Type
Active Comparator
Arm Title
sevofluorane
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
anaesthetics: sevofluorane
Intervention Description
0.5%of sevofluorane with air
Primary Outcome Measure Information:
Title
episode of severe arterial hypotension
Time Frame
at 0 minut, after 3 minuts, after 5 minuts
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Federico F Bilotta
Phone
+39 339 33 70 822
Email
bilotta@tiscali.it
Facility Information:
Facility Name
Policlinico UMBERTO I
City
Rome
ZIP/Postal Code
00100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Federico F Bilotta
Phone
+39 339 33 70 822
Email
bilotta@tiscali.it

12. IPD Sharing Statement

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Anesthesia Induction in Patients Undergoing Surgery for Cervical Myelopathy

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