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

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Yonsei University

Status and phase

Completed
Phase 4

Conditions

Sedation

Treatments

Drug: Midazolam infusion
Drug: Propofol infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT01527903
4-2009-0311

Details and patient eligibility

About

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.

Full 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.

Enrollment

77 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

77 participants in 2 patient groups

Propofol
Active Comparator group
Treatment:
Drug: Propofol infusion
Midazolam
Active Comparator group
Treatment:
Drug: Midazolam infusion

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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