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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sedation

Intervention / Treatment
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* Drug: Propofol infusion
* Drug: Midazolam infusion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br> | Drug: Propofol infusion<br>* 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<br>|
| Active Comparator: Midazolam<br> | Drug: Midazolam infusion<br>* midazolam at a rate of 0.1 mg kg-1 h-1, increments or decrements of 0.05 mg kg-1 h-1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extubation time | the time to extubation : defined as the time from discontinuation of infusion to extubation | monitored from dicontinuation of sedatives to extubation, during an expected average of 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delirium | delirium assessed by Confusion Assessment Method for ICU (CAM-ICU) | monitored during the entire ICU stay (an expected average of 6 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICU, propofol, midazolam, sedation