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

Yonsei University77 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sedation

Interventions

Propofol infusionDRUG

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 infusionDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Severance Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Extubation time

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

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

Secondary Outcomes

delirium

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

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

Data from ClinicalTrials.gov

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