Sevoflurane in Subarachnoidal Haemorrhage

Subarachnoid Haemorrhage (SAH) Clinical Trial

— Sevoflurane  

Official title:

Short Term Application of Sevoflurane in Patients With Subarachnoid Haemorrhage: a Feasibility and Safety Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02946437
• Other study ID #: 2014-0397
• Secondary ID: 2015DR2134
• Status: Withdrawn
• Phase: Phase 2
• Start date: November 1, 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Feasibility and safety of short term application of sevoflurane in patients with SAH treated with aneurysm coiling or clipping in the setting of a neurointensive care unit.

Description:

After admission to the ICU, before the coiling / clipping intervention has been performed, the patients are screened for eligibility. When the patients are coming back to the ICU, after successful aneurysm coiling or clipping, data of artificial ventilation, systemic and other cerebral parameters will be collected continuously by online monitoring, starting at baseline and stopping at discharge of the ICU. Sevoflurane will be vaporized and administrated by the MIRUS™System directly to the inspiratory part of the ventilation circuit for the next 4 hours. In the following 14 days of the stay on the ICU, standard monitoring parameters, the appearance of vasospasm and brain oedema will be recorded. Besides the continuous online monitoring, laboratory assessment will be performed daily. At day 7±2 and day 14±2 after bleeding a MRI or CT examination will be performed, according to the clinical condition of the patient, to detect secondary brain injuries, as ischemia or brain oedema. At ICU discharge, the neurological outcome will be assesses applying GOS.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients of either sex aged 18-85 years

• Patients with severe aneurysmal SAH, Hunt/Hess 3 to 5.

• The ruptured aneurysm is successfully excluded with coiling or clipping

• Sedation and mechanical ventilation necessary due to the clinical situation

• ICP monitoring in use due to the clinical situation

• ICP < 20mmHg without medical treatment

• Systolic blood pressure values (BP syst) > 120 mmHg with no need for catecholamines

• Female patients of childbearing potential with negative pre-treatment serum pregnancy test

• Informed consent obtained

Exclusion Criteria:

• Significant kidney disease, defined as plasma creatinine >120 µmol/l

• Significant liver disease, defined as Aspartate-Aminotransferase (AST) >200 U/l

• Significant elongation of the QTc interval: female < 470 msec/ male < 450 msec; based on 'Bazett's Formula'

• History of epilepsia and/ or occurring seizures with aneurysm rupture

• Pneumocephalus after surgery excluded by CT scan performed immediately after clipping

• History of allergic disorders

• History for, or relatives with a history for malignant hyperthermia

• History or signs for neuromuscular disease

• Pre-existing disability

• Patients participating in an interventional clinical trial within the last 30 days before start of treatment

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Haemorrhage (SAH)
• Subarachnoid Hemorrhage

Intervention

Drug:
• Sevoflurane
Postconditioning with sevoflurane (0.5-1.5vol%) for 4 hours after coiling or clipping of cerebral aneurysm in patients with severe SAH
• Propofol
Before and after postconditioning with sevoflurane the patients will be sedated with intravenous sedatives (midazolam or propofol). The quality of sedation before the postconditioning (propofol or midazolam) will be compared to the sedation one hour after starting the postconditioning (sevoflurane) in the same patient.
• Midazolam
Before and after postconditioning with sevoflurane the patients will be sedated with intravenous sedatives (midazolam or propofol). The quality of sedation before the postconditioning (propofol or midazolam) will be compared to the sedation one hour after starting the postconditioning (sevoflurane) in the same patient.

Device:
• MIRUS™System
The MIRUS™System is the normally used standard equipment for the administration of volatile anaesthetics to patients.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: Incidence of concerns/problems in the use of sevoflurane by intensivist and ICU nurse at the stopping of sevoflurane postconditioning.	Incidence of concerns of users in relation to the application of standard sedation with propofol or midazolam; Incidence of complications with sevoflurane preparation, sevoflurane application, MIRUS™-installation, MIRUS™-function, MIRUS™-removal; User friendliness compared to settings for artificial ventilation supplemented with NO	4 hours
Secondary	Quality of sedation	Incidence of insufficient sedation during postconditioning with sevoflurane, measured with: Ramsay Sedation Scale (RSS <2); Richmond Agitation-Sedation Scale (RASS >0); Bispectral index (BIS >30); Incidence of use of additional sedative medication as midazolam, propofol; in relation to the sedation regimen before and after the postconditioning (dose and use of additional sedative medication as midazolam, propofol)	5 hours
Secondary	Neuroprotective effects	Number of days during the 14 days monitoring period with signs of DIND; incidence of new neurological deficits on daily clinical visits; incidence of 2 consecutive metabolic crisis identified by microdialysis, defined as lactate/pyrovate-ratio (L/P-ratio) >40; incidence of PtiO2 <20mmHg at least 60 minutes- immediately before the measurement; incidence of new perfusion deficits in perfusion-CT and/ or -MRI, new infarctions in contrast enhanced CT/ MRI; Neurological outcome (GOS) will be assessed at ICU discharge and compared to data from the literature.	14 days