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Completed

NCT Number: NCT01527903

A Comparison Between Propofol-Remifentanil and Midazolam-Remifentanil Sedation in the Intensive Care Unit

The purpose of this study is to compare propofol-remifentanil sedation with midazolam-remifentanil sedation in regards to extubation and weaning time, length of stay in the ICU, as well as the incidence of delirium. Primary end-points were weaning time and extubation time, and secondary end-points were the incidence of delirium and length of stay in the ICU.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Severance Hospital

Seoul, 120-752, South Korea

About this study

With on-going emphasis on early extubation, as well as further recognition of morbidity and mortality associated with delirium, the specific sedatives and analgesics used in the ICU is an issue of interest. Recent studies have focused on comparing sedatives, but interpretations are often confounded by the fact that in most studies, different analgesics were used when comparing two sedative medications. The role of remifentanil as the main analgesic in the ICU is being recognized. Pharmacodynamic and pharmacokinetic profiles of remifentanil makes it an ideal analgesic in the ICU setting. The investigators therefore designed this randomized study to compare sedation with propofol and midazolam in a remifentanil-based sedation and analgesia.

The purpose of this study is to compare propofol-remifentanil sedation with midazolam-remifentanil sedation in regards to extubation and weaning time, length of stay in the ICU, as well as the incidence of delirium. Primary end-points were weaning time and extubation time, and secondary end-points were the incidence of delirium and length of stay in the ICU.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • surgical patients over 18 years old who were admitted to the ICU for postoperative ventilator care after sevoflurane-remifentanil based general anesthesia

Exclusion criteria

  • pre-existing neurologic dysfunction (dementia)
  • head trauma patients
  • previous history of alcohol abuse or substance abuse
  • patients who had baseline serum creatinin levels of over 2.5mg/100ml
  • uncompensated liver cirrhosis
  • hemorrhagic, cardiogenic, or septic shock
  • pregnancy or breast feeding
  • tracheostomy or extubation before ICU admission.

Treatment and study plan

Propofol infusion

Drug

IV propofol 2% at a rate of 1.0 mg kg-1 h-1, increments or decrements of 0.1 mg kg-1 h-1

Midazolam infusion

Drug

midazolam at a rate of 0.1 mg kg-1 h-1, increments or decrements of 0.05 mg kg-1 h-1

Primary outcomes

  1. Extubation time

    Time frame: monitored from dicontinuation of sedatives to extubation, during an expected average of 3 hours

    the time to extubation : defined as the time from discontinuation of infusion to extubation

Secondary outcomes

  1. delirium

    Time frame: monitored during the entire ICU stay (an expected average of 6 days)

    delirium assessed by Confusion Assessment Method for ICU (CAM-ICU)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Sedation of Surgical Patients in the Intensive Care Unit: A Randomized Comparison Between Propofol-Remifentanil and Midazolam-Remifentanil Sedation

Acronym: ICU

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 7, 2012
Registry last updated
Aug 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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