Use of Classic LMA During Endovascular Therapy

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Brief Title

Use of Classic LMA During Endovascular Therapy

Official Title

The Use of the Classic Laryngeal Mask Airway in Patients With Cerebral Aneurysm Undergoing Endovascular Therapy

Brief Summary

      Background: Earlier treatment and resolution for patients with cerebral aneurysms is now
      possible due to earlier diagnosis. This observational study aims to evaluate the
      intraoperative cardiovascular parameters in patients with cerebral aneurysms undergoing
      endovascular therapy.

      Method: This is an observational prospective study. Patients ≥ 18 years old diagnosed with an
      unruptured cerebral aneurysm or subarachnoid hemorrhage (SAH) (Hunt & Hess grade I or II)
      undergoing endovascular treatment under general anesthesia between April 2015 and February
      2017 were included. Non-invasive measurements of hemodynamic variables were collected at six
      time points during the procedure (T1 to T6). Statistical analysis was performed by using
      central tendency measures for quantitative variables and absolute / relative frequency
      measurements for qualitative variables.
    

Detailed Description

      Objective

      • To assess the usefulness of general anesthesia with Laryngeal Mask Airway (LMA)-Classic for
      the endovascular treatment of cerebral aneurysms based on cardiovascular stability analysis
      Data collection Anesthetic protocol was standardized for all patients consisting of an
      intravenous induction with fentanyl (1-2 μg/kg), lidocaine (1.5 mg/kg), propofol (2 mg/kg),
      and dexamethasone (8 mg) followed by the insertion of the LMA-Classic. Sevoflurane with a
      minimal alveolar concentration (MAC) between 0.9 and 1.1%, dipyrone (2 gr IV), and morphine
      (0.05 mg/kg IV) were used during maintenance. Tidal volume (VT) and respiratory rate (RR)
      were adjusted to 7 ml/Kg and 12-14 per minute respectively. Non-invasive hemodynamic
      monitoring included mean arterial pressure (MAP), heart rate (HR), oxygen saturation, and
      end-tidal carbon dioxide (ETCO2).

      Data was collected within six time points: Time point 1: before induction, Time point 2:
      after induction, Time point 3: after LMA-Classic insertion, Time point 4: during the
      endovascular procedure, Time point 5: during coiling, and Time point 6: at the end of the
      procedure and LMA-Classic removal.

      The following demographic and clinical data were collected: age, gender, American Society of
      Anesthesiologists Physical Status (ASA-PS), total procedure time, comorbidities, aneurysm
      location, and associated clinical manifestations. Adverse events, such as intraoperative
      aneurysm rupture or need for endotracheal intubation, will be recorded.

      Ethical considerations Approvals were obtained from the ethics committees at Antioquia
      University and Especialidades Médicas Metropolitanas Sociedad Anónima (EMMSA) Clinic.
      Patients signed an informed consent and confidentiality agreement before participating.

      Statistical analysis Data was collected in an excel spreadsheet (Microsoft Excel 2010®), SAS
      9.4 (SAS Institute, Cary, N.C.) was used for subsequent analysis. Continuous variables were
      summarized as means and standard deviations (SD). Categorical variables were summarized as
      frequencies and percentages. Linear mixed models were fit to model continuous clinical
      variables over time using contrasts to test differences between time points. P-values less
      than 0.05 were considered to be statistically significant.
    


Study Type

Observational


Primary Outcome

Hemodynamic changes (changes from baseline in Heart Rate and Mean Arterial Pressure)


Condition

Cerebral Aneurysm Unruptured



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

60

Start Date

April 1, 2015

Completion Date

February 28, 2017

Primary Completion Date

February 28, 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Patients ≥ 18 years old

          -  Diagnosed with an unruptured cerebral aneurysm or SAH (Hunt & Hess grade I or II)

          -  Planned to undergo endovascular therapy under general anesthesia between April 2015
             and February 2017 in the Especialidades Médicas Metropolitanas Sociedad Anónima
             (EMMSA) Clinic in Bello, Antioquia, Colombia

        Exclusion Criteria:

          -  Patients diagnosed with a cerebral aneurysm undergoing craniotomy and clipping and
             patients with SAH (Hunt & Hess grade > II).
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Francisco J Gomez Oquendo, MD, , 



Administrative Informations


NCT ID

NCT03288519

Organization ID

001


Responsible Party

Sponsor

Study Sponsor

Universidad de Antioquia


Study Sponsor

Francisco J Gomez Oquendo, MD, Principal Investigator, Department of Anesthesiology, University of Antioquia, Medellin, Colombia.


Verification Date

September 2017