Not Yet RecruitingPhase 2Phase 3ACTRN12611000166976

Sedation Practice in Intensive Care in Australia and New Zealand- A Pilot Study

A randomised controlled trial of a sedative regimen that utilises dexmedetomidine as the primary agent and minimises the use of midazolam compared with current sedation practice in intensive care patients on outcomes of mortality, cognitive function and Health Related Quality of Life.

Sponsor

ANZIC-research centre, Monash University

Enrollment

60 participants

Start Date

Apr 11, 2011

Study Type

Interventional

Conditions

Sedation in intensive care patients

Summary

The purpose of the SPICE Pilot RCT is to obtain preliminary data on the feasibility of conducting a large phase III RCT. The hypothesis of the proposed RCT is that a sedation regimen based on dexmedetomidine as the primary sedative agent, and in which benzodiazepine use is minimised, will lead to improved patient centred outcomes.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares different sedation approaches for adults aged 18 and older who are on a breathing machine in intensive care. Participants must need ongoing sedation and be expected to remain on the ventilator for at least two more days. People with brain injuries, spinal cord injuries, drug overdoses, burn injuries, or end-stage liver failure cannot participate.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Arm 1 Known as Grp DexP-sedation regime with dexmedetomidine as the primary agent. Dexmedetomidine up to 1 to 1.5 mcg/kg/hour to achieve desired sedation level. Given via infusion as required for up

Arm 1 Known as Grp DexP-sedation regime with dexmedetomidine as the primary agent. Dexmedetomidine up to 1 to 1.5 mcg/kg/hour to achieve desired sedation level. Given via infusion as required for up to a max of 30 days. Arm 2 Grp Std care- standard care sedation as per site's normal practice. Given via infusion as required.

Locations(1)

Auckland, New Zealand

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12611000166976