Use of Classic LMA During Endovascular Therapy

NCT03288519 | Completed

• 1 other identifier: 001
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebral Aneurysm Unruptured; Cerebral Aneurysm; Hemodynamic Instability; Airway Morbidity

Keywords

Cerebral aneurysm; Endovascular therapy; Classic laryngeal mask airway; Hemodynamic changes

Outcome Measures

Primary Outcomes (1)

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

  • To assess the usefulness of general anesthesia with LMA-Classic for the endovascular treatment of cerebral aneurysms based on cardiovascular stability analysis

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Antioquia: lead

Related Publications (6)

• Brown RD Jr, Broderick JP. Unruptured intracranial aneurysms: epidemiology, natural history, management options, and familial screening. Lancet Neurol. 2014 Apr;13(4):393-404. doi: 10.1016/S1474-4422(14)70015-8.

  PMID: 24646873 BACKGROUND

• Brisman JL, Song JK, Newell DW. Cerebral aneurysms. N Engl J Med. 2006 Aug 31;355(9):928-39. doi: 10.1056/NEJMra052760. No abstract available.

  PMID: 16943405 BACKGROUND

• Weir B, Disney L, Karrison T. Sizes of ruptured and unruptured aneurysms in relation to their sites and the ages of patients. J Neurosurg. 2002 Jan;96(1):64-70. doi: 10.3171/jns.2002.96.1.0064.

  PMID: 11794606 BACKGROUND

• Chowdhury T, Cappellani RB, Sandu N, Schaller B, Daya J. Perioperative variables contributing to the rupture of intracranial aneurysm: an update. ScientificWorldJournal. 2013 Nov 12;2013:396404. doi: 10.1155/2013/396404.

  PMID: 24324371 BACKGROUND

• Lee CZ, Young WL. Anesthesia for endovascular neurosurgery and interventional neuroradiology. Anesthesiol Clin. 2012 Jun;30(2):127-47. doi: 10.1016/j.anclin.2012.05.009. Epub 2012 Jul 13.

  PMID: 22901603 RESULT

• Kundra S, Mahendru V, Gupta V, Choudhary AK. Principles of neuroanesthesia in aneurysmal subarachnoid hemorrhage. J Anaesthesiol Clin Pharmacol. 2014 Jul;30(3):328-37. doi: 10.4103/0970-9185.137261.

  PMID: 25190938 RESULT

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Francisco J Gomez Oquendo, MD

  Department of Anesthesiology, University of Antioquia, Medellin, Colombia.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 20, 2017
• Study Start: April 1, 2015
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: December 19, 2018

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share