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

Summary

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.

Conditions

• Critical Illness
• Mechanical Ventilation Complication

Interventions

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.

Sponsors & Collaborators

• Ospedale San Paolo

  collaborator OTHER

• Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

  collaborator OTHER

• Azienda Ospedaliera San Gerardo di Monza

  collaborator OTHER

• Azienda Ospedaliera Niguarda Cà Granda

  collaborator OTHER

• Azienda Ospedaliera Fatebenefratelli e Oftalmico

  collaborator OTHER

• Fondazione IRCCS Policlinico San Matteo di Pavia

  collaborator OTHER

• San Luigi Gonzaga Hospital

  collaborator OTHER

• Ospedale S. Giovanni Bosco

  collaborator OTHER

• Ospedale Cardinal Massaia

  collaborator OTHER

• Azienda Ospedaliera, Ospedale Civile di Legnano

  collaborator OTHER

• Nuovo Ospedale Civile S.Agostino Estense

  collaborator OTHER

• University of Milan

  lead OTHER

Principal Investigators

• Iapichino Gaetano, MD · University of Milan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2012-10-31

Completion

2012-12-31

Countries

• Italy

Study Locations