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

Sedation Clinical Trial

— ICU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01527903
• Other study ID #: 4-2009-0311
• Status: Completed
• Phase: Phase 4
• First received: January 24, 2012
• Last updated: August 16, 2016
• Start date: September 2009
• Est. completion date: June 2010

Study information

• Verified date: August 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sedation

Intervention

Drug:
• Propofol infusion
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 infusion
midazolam at a rate of 0.1 mg kg-1 h-1, increments or decrements of 0.05 mg kg-1 h-1

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	delirium	delirium assessed by Confusion Assessment Method for ICU (CAM-ICU)	monitored during the entire ICU stay (an expected average of 6 days)	No