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

Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2012
INTERVENTION: 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: Sevoflurane Product Code: NA Pharmaceutical Form: Inhalation gas INN or Proposed INN: Sevoflurane Concentration unit: ml millilitre(s) Concentration number: 250‐ CONDITION: surgery for cervical myelopathy Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: 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 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 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 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
Epistemonikos ID: d18b8740eb8e0463129329d7d17a01c6a6c29184
First added on: Aug 22, 2024