Sevoflurane in Subarachnoidal Haemorrhage

• Status: Withdrawn
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Treatments: Midazolam; Propofol; Sevoflurane

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