Skip to content

Propofol-based or Sevoflurane-based Anesthesia Induction in Patients Undergoing Fiberoptic Tracheal Intubation for Cervical Spine Surgery: Effects on Systemic Hemodynamics and Respiratory Drive- the Blade Runner Trial - The Blade Runner Trial

Propofol-based or Sevoflurane-based Anesthesia Induction in Patients Undergoing Fiberoptic Tracheal Intubation for Cervical Spine Surgery: Effects on Systemic Hemodynamics and Respiratory Drive- the Blade Runner Trial - The Blade Runner Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-000790-31-IT
Enrollment
116
Registered
2012-03-05
Start date
2011-04-29
Completion date
Unknown
Last updated
2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

surgery for cervical myelopathy

Interventions

Product Name: NA Product Code: NA Pharmaceutical Form: Emulsion for infusion INN or Proposed INN: Propofol Concentration unit: mg/ml milligram(s)/millilitre Concentration number: 10- Product Name: Se

Sponsors

AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with acute symptoms or signs of cervical myelopathy undergoing cervical spine surgery, aged 18 to 75 years, classified as American Society of Anesthesiology physical status (ASA) I-III, were enrolled Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with preoperative hemodynamic instability and pulmonary failure were excluded from the study.

Design outcomes

Primary

MeasureTime frame
Main Objective: This trial was designed to evaluate the hemodynamic and ventilator effects of propofol-based or sevoflurane-based anesthesia induction, in patients undergoing surgery for cervical myelopathy;Secondary Objective: Secondary end-points included the relationship between the two anesthesia induction strategies and intubation conditions as assessed by the Copenhagen score rearranged for fiberoptic intubation, according to jaw relaxation, resistance to fiberoptic bronchoscopy, vocal cord position and movements and reaction to cuff inflation;Primary end point(s): The MAP was measured at 4 time points: before anesthesia induction (T1: baseline), at the end of anesthesia induction when an adequate sedation level, with BIS values 40-50, was achieved (T2: sedation steady state); immediately after placement of the endotracheal tube (T3: intubation); five minutes after tracheal intubation (T4: post-intubation).

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026