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Use of Classic LMA During Endovascular Therapy

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ClinicalTrials.gov Identifier: NCT03288519
Recruitment Status : Completed
First Posted : September 20, 2017
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Universidad de Antioquia

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.


Condition or disease
Cerebral Aneurysm Unruptured Cerebral Aneurysm Hemodynamic Instability Airway Morbidity

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.


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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Use of the Classic Laryngeal Mask Airway in Patients With Cerebral Aneurysm Undergoing Endovascular Therapy
Actual Study Start Date : April 1, 2015
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms




Primary Outcome Measures :
  1. Hemodynamic changes (changes from baseline in Heart Rate and Mean Arterial Pressure) [ Time Frame: Outcome measure will be assessed from baseline (defined as time point 1, before induction) until the end of the surgery and laryngeal mask removal (defined as time point 6). Data will be reported within one year after study completion ]
    • To assess the usefulness of general anesthesia with LMA-Classic for the endovascular treatment of cerebral aneurysms based on cardiovascular stability analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
An observational prospective study was undertaken in the Especialidades Médicas Metropolitanas Sociedad Anónima (EMMSA) Clinic in Bello, Antioquia, Colombia. The investigators included patients ≥ 18 years old diagnosed with an unruptured cerebral aneurysm or SAH (Hunt & Hess grade I or II) undergoing endovascular treatment under general anesthesia between April 2015 and February 2017. The investigators excluded patients diagnosed with a cerebral aneurysm undergoing craniotomy and clipping and patients with SAH (Hunt & Hess grade > II).
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03288519


Sponsors and Collaborators
Universidad de Antioquia
Investigators
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Principal Investigator: Francisco J Gomez Oquendo, MD Department of Anesthesiology, University of Antioquia, Medellin, Colombia.

Publications of Results:
Other Publications:
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Responsible Party: Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT03288519     History of Changes
Other Study ID Numbers: 001
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: De-identified data will be shared with our colleagues at The Ohio State University for posterior data analysis

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universidad de Antioquia:
Cerebral aneurysm
Endovascular therapy
Classic laryngeal mask airway
Hemodynamic changes

Additional relevant MeSH terms:
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Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases