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

Conditions: surgery for cervical myelopathy
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2011-000790-31-IT

Lead Sponsor: AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 116

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures