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

Phase 4

Completed

• Conditions: Sedation
• Interventions: Drug: Propofol infusion; Drug: Midazolam infusion

• Registration Number: NCT01527903
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Study First Submitted: 2012-01-24
• Study First Submitted QC: 2012-02-06
• Study First Posted: 2012-02-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol infusion	-
Midazolam	Midazolam infusion	-

Primary Outcome Measures

Name	Time	Method
Extubation time	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 Outcome Measures

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

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of