Critical Illness | Enteral Versus Intravenous Sedation in Critically Ill High-risk ICU Patients

Critical Illness research study

What is the primary objective of this study?

Recent studies suggest the employment of 'conscious' sedation (1) for critically high - risk patients (2), showing more efficacy then deep sedation (3). The investigators want to compare intravenous injection versus enteral sedative drugs administration, purposing to maintain a 'conscious' sedation level compatibly with the needed cares, invasive procedures, and medical and nursing surveillance.

Who is eligible to participate?

Inclusion Criteria: - High Risk Patients (Ventilation days assessment >3, SAPS II >32). - Until 24 h after ICU admission - Age > 18 years Exclusion Criteria: - Neurosurgical patients - Allergy to medications used in the study - CNS diseases (epilepsy, ictus, dementia, anoxic coma…) - Liver encephalopathy (Child C) - Previous psychiatric or cognitive pathology - Absolute contraindications to use enteral route (acceptable NGT, digiunostomy, ileostomy) - Pregnant patients or in breast-feeding - DNR patients

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Critical Illness

Mechanical Ventilation Complication

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:Enteral Sedation (EN)Intravenous propofol or midazolam administration at the ICU admission and stopped within 48h. Melatonin by enteral route (3mg x 2/die) from admission to discharge. Hydroxyzine by enteral route from ICU admission (600mg/die), decreased and stopped as soon as possible. Lorazepam supplementation (maximum 16mg/die) if hydroxyzine is inadequate.

Procedure:Control group: Intravenous Sedation (IV)Propofol or midazolam from ICU admission to discharge at the compatible lowest level with harsh ICU environment.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Enteral Sedation (EN)Melatonin, Hydroxyzine, and Lorazepam. At every work shift, it will be checked the possibility to decrease the Lorazepam and then the Hydroxyzine dosage to quickly obtain and continuously maintain a RASS level = 0

Intravenous Sedation (IV)Intravenous propofol or midazolam administration at the ICU admission to discharge at the compatible lowest level with harsh ICU environment. At every shift nurses are requested to give intravenous lowest dosage to obtain RASS=0

Study Status

Unknown status

Start Date: January 2012

Completed Date: December 2012

Phase: Phase 3

Type: Interventional


Primary Outcome: Percent of efficacy, measured by observed RASS = desired RASS ± 1.

Secondary Outcome: Sedation protocol effectiveness: percentage of "protocol violation days" on the total of ICU days.

Study sponsors, principal investigator, and references

Principal Investigator: Iapichino Gaetano, MD

Lead Sponsor: University of Milan

Collaborator: Ospedale San Paolo

More information:

Strøm T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial. Lancet. 2010 Feb 6;375(9713):475-80. doi: 10.1016/S0140-6736(09)62072-9. Epub 2010 Jan 29.

Discuss Lorazepam