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

This study is currently recruiting participants.
Verified February 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01527903
First received: January 24, 2012
Last updated: February 6, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Sedation
 Drug: Propofol infusion
Drug: Midazolam infusion
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sedation of Surgical Patients in the Intensive Care Unit: A Randomized Comparison Between Propofol-Remifentanil and Midazolam-Remifentanil Sedation

Resource links provided by NLM:

MedlinePlus related topics: Delirium
U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Extubation time [ Time Frame: monitored from dicontinuation of sedatives to extubation, during an expected average of 3 hours ] [ Designated as safety issue: No ]
    the time to extubation : defined as the time from discontinuation of infusion to extubation


Secondary Outcome Measures:
  • delirium [ Time Frame: monitored during the entire ICU stay (an expected average of 6 days) ] [ Designated as safety issue: No ]
    delirium assessed by Confusion Assessment Method for ICU (CAM-ICU)


Estimated Enrollment: 80
Study Start Date: September 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Propofol Drug: Propofol infusion
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
Active Comparator: Midazolam Drug: Midazolam infusion
midazolam at a rate of 0.1 mg kg-1 h-1, increments or decrements of 0.05 mg kg-1 h-1

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01527903

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Shin Ok Koh         graydavid@naver.com    
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01527903     History of Changes
Other Study ID Numbers: 4-2009-0311
Study First Received: January 24, 2012
Last Updated: February 6, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yonsei University:
propofol
midazolam
sedation
ICU

Additional relevant MeSH terms:
Midazolam
Propofol
Remifentanil
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
 Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 13, 2013