Clinical trial NCT02946437: Sevoflurane in Subarachnoidal Haemorrhage
Official title: Short Term Application of Sevoflurane in Patients With Subarachnoid Haemorrhage: a Feasibility and Safety Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Subarachnoid Haemorrhage (SAH)
Keywords: severe SAH
prevention of vasospasm and/ or brain oedema
Sevoflurane
Postconditioning
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-10-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility: Incidence of concerns/problems in the use of sevoflurane by intensivist and ICU nurse at the stopping of sevoflurane postconditioning.
timeFrame: 4 hours
Secondary outcomes:
measure: Quality of sedation
timeFrame: 5 hours
measure: Neuroprotective effects
timeFrame: 14 days
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Emanuela Keller, MD Prof.
role: PRINCIPAL_INVESTIGATOR
References: