Sedation of Surgical Patients in the Intensive Care Unit: A Randomized Comparison Between Propofol-Remifentanil and Midazolam-Remifentanil Sedation
Overview
- Phase
- Phase 4
- Intervention
- Propofol infusion
- Conditions
- Sedation
- Sponsor
- Yonsei University
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- Extubation time
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
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.
Investigators
Eligibility 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.
Arms & Interventions
Propofol
Intervention: Propofol infusion
Midazolam
Intervention: Midazolam infusion
Outcomes
Primary Outcomes
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
- delirium(monitored during the entire ICU stay (an expected average of 6 days))