Spinal Cord DiseasesPhase 4Blade runnerNCT01052337
Anesthesia Induction in Patients Undergoing Surgery for Cervical Myelopathy
A Phase 4 study testing anaesthetics: sevofluorane in people with Spinal Cord Diseases, run by University of Roma La Sapienza at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Diseases
- What is being tested?
- anaesthetics: sevofluorane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2009to Mar 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing cervical spine surgery;
- Male or female;
- Aged 18-75 years.
Who cannot join
- Severe cardiovascular pathology;
- Liver disease;
- Renal disease;
- BMI >35;
- Allergies to any anaesthetic drugs.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Policlinico UMBERTO I
Rome, Rome, 00100
Federico F Bilotta, +39 339 33 70 822, bilotta@tiscali.it
About this study
Official title: Anesthesia Induction With Propofol or Sevoflurane in Patients Undergoing Fiberoptic Intubation for Cervical Myelopathy: Effects on Heamodynamics
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.
Read the 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.
- Conditions
- Spinal Cord Diseases
- Being tested
- anaesthetics: sevofluorane
- Medical subject headings
- Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anaesthetics: sevofluoraneDrug
0.5%of sevofluorane with air
| Study group | Role | What they receive |
|---|---|---|
| propofol | Active comparator | Not described Receives: Drug: anaesthetics: sevofluorane |
| sevofluorane | Active comparator | Not described Receives: Drug: anaesthetics: sevofluorane |
What is being measured
The primary outcome is the main question the study is designed to answer.
episode of severe arterial hypotension
Measured: at 0 minut, after 3 minuts, after 5 minuts
Secondary outcomes (1)
the incidence and duration of apnoea and the incidence of induction complications such as laryngospasm, coughing and patient movement during fiberoptic intubation.
Measured: at 0 minuts , at 5 minuts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startApr 2009
- Primary completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord DiseasesStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052337
- Sponsor's protocol ID
- Blade-runner
- Acronym
- Blade runner
- Status last verified
- Dec 2009
- First submitted
- 12 Jan 2010
- Last updated
- 20 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesia Induction With Propofol or Sevoflurane in Patients Undergoing Fiberoptic Intubation for Cervical Myelopathy: Effects on Heamodynamics
- ClinicalTrials.gov ID
- NCT01052337
- Acronym / sponsor ID
- Blade runner / Blade-runner
- Conditions
- Spinal Cord Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Mar 2010 (estimated)
- First posted
- 20 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol | Active comparator | Drug: anaesthetics: sevofluorane |
| sevofluorane | Active comparator | Drug: anaesthetics: sevofluorane |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient undergoing cervical spine surgery;
- Male or female;
- Aged 18-75 years.
Key exclusion criteria (5 listed)
- Severe cardiovascular pathology;
- Liver disease;
- Renal disease;
- BMI >35;
- Allergies to any anaesthetic drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anaesthetics: sevofluorane0.5%of sevofluorane with air | Drug | propofol, sevofluorane |
Primary outcome
episode of severe arterial hypotension
Time frame: at 0 minut, after 3 minuts, after 5 minuts
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing anaesthetics: sevofluorane in people with Spinal Cord Diseases, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Federico F Bilotta (+39 339 33 70 822, bilotta@tiscali.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
episode of severe arterial hypotension (time frame: at 0 minut, after 3 minuts, after 5 minuts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2010; AzTrials last refreshed its copy on 6 Nov 2026.