Use of Classic LMA During Endovascular Therapy

Hemodynamic Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03288519
• Other study ID #: 001
• Status: Completed
• Start date: April 1, 2015
• Est. completion date: February 28, 2017

Study information

• Verified date: September 2017
• Source: Universidad de Antioquia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Airway Morbidity
• Aneurysm
• Cerebral Aneurysm
• Cerebral Aneurysm Unruptured
• Hemodynamic Instability
• Intracranial Aneurysm

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Antioquia

References & Publications (6)

Brisman JL, Song JK, Newell DW. Cerebral aneurysms. N Engl J Med. 2006 Aug 31;355(9):928-39. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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