Sedation Depth in Neurocritical Care

Summary

Background: Sedation of the intensive care unit (ICU) patient is necessary to relieve the patient from pain, anxiety and agitation and to enable mechanical ventilation, diagnostic investigations and invasive procedures. While sedation policy has shifted from deep sedation to moderate, minimal, or even no sedation in the general ICU, optimal sedation of the cerebrovascular ICU patient is unclear and controversial.

Method: MOderate vs DEep Regime in NeuroIntensive care SEdation (MODERNISE) is a prospective, randomized, open, two-center trial. Patients with acute ischemic stroke, intracerebral hemorrhage or subarachnoid hemorrhage who need to be ventilated are eligible for enrollment. It is intended to enroll 50 patients per group (n=100). Patients are randomized within 72h from admission to either moderate sedation as defined by Richmond Agitation Sedation Scale (RASS) \>= -3 or to deep sedation as defined by RASS \< -3 for the next 72h, after which weaning from sedation is aimed for in a stepwise fashion in both groups. If reduction of sedation is not feasible, patients remain at their respective sedation level for another 12 hours, and sedation reduction is then tried again. Patients are multimodally monitored for systemic and cerebral parameters (the latter including bispectral index (BIS) monitoring). The primary endpoint is ICU length of stay (ICU-LOS); secondary endpoints are several pre-defined variables of the ICU course, feasibility of sedation levels without violation of pre-defined safety criteria, pre-defined complications, and short- and long-term functional outcome and mortality.

Conclusion: The feasibility, safety and benefits of moderate as opposed to deep sedation even in the acute phase of severe cerebrovascular disease needs to be clarified in a prospective randomized study. Results from this study might change sedation regimes and help prevent unwanted effects of deep sedation in the brain-injured patient.

Conditions

• Sedation of Cerebrovascular Ventilated Critical Care Patients

Interventions

OTHER

Intensive Care Sedation (depth, level)

As far as sedation is concerned, this will be adapted to all patients before randomization in the first 3 days according to what the diagnosis and acute treatment of the underlying disease demands. This will be deep sedation or even general anesthesia (for operative procedures) in most cases. After 72h at the sedation level of the respective randomization result, both groups will tried to be weaned from sedation with the goal of awakening, weaning from ventilation, overall de-escalation and transfer to rehabilitation as far as the course of the disease and the occurrence of complications allows. This reduction of sedation will follow individual regimes at he discretion of the treating physician. However, if cessation of sedation violates safety-limits (see below, Tab. 2) or is not feasible for other reasons, return to the level the patient was initially randomized for (or even below that) is mandatory with a re-assessment of safety for sedation weaning after 12h aimed for.

DRUG

Vasopressors to maintain normal blood pressure values, if needed

DRUG

Osmotherapeutics to lowr intracranial pressure, if needed

PROCEDURE

Endovascular stroke care to treat brain vessel occlusions, if needed

PROCEDURE

Decompressive neurosurgery, if needed

Sponsors & Collaborators

• Heidelberg University

  lead OTHER

Principal Investigators

• Julian Bösel, MD · Dep. of Neurology, University of Heidelberg, Germany

• Alejandro Rabinstein, MD · Dep. of Neurology, Mayo Clinic, Rochester, USA

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-30

Primary Completion

2018-01-31

Completion

2018-11-30

Countries

• Germany

Study Locations