NCT01527903

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 7, 2012

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

9 months

First QC Date

January 24, 2012

Last Update Submit

August 16, 2016

Conditions

Sedation

Keywords

propofolmidazolamsedationICU

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • delirium

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

Study Arms (2)

Propofol

ACTIVE COMPARATOR
Drug: Propofol infusion

Midazolam

ACTIVE COMPARATOR
Drug: Midazolam infusion

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

Propofol
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

Midazolam

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • surgical patients over 18 years old who were admitted to the ICU for postoperative ventilator care after sevoflurane-remifentanil based general anesthesia

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2012

First Posted

February 7, 2012

Study Start

September 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

August 17, 2016

Record last verified: 2016-08

Locations

KR(1)