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Status:

TERMINATED

A Study Comparing Two Analgesia/Sedation Regimens, Remifentanil/Propofol Versus Sufentanil/Propofol In Mechanically Ventilated Intensive Care Patients Requiring Analgesia And Sedation.

Lead Sponsor:

GlaxoSmithKline

Conditions:

Analgesia

Sedation

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

This prospective, randomized, multicenter, open-label study will compare two analgesia-based regimens for sedation (remifentanil/propofol vs. sufentanil/propofol) in medium to long-term ventilated int...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA
  • Written informed consent was obtained from the patient
  • The patient is under intensive medical care, intubated and ventilated
  • The expected duration of ventilation and analgesia/sedation is \> 24 hours and \</= 7 days
  • Propofol is planned to be used as sedative
  • EXCLUSION CRITERIA
  • Contraindication against administration of remifentanil, sufentanil, or propofol
  • Concomitant medications:
  • The patient is receiving epidural analgesia or a peripheral regional anesthetic therapy.
  • The patient is requiring muscle relaxants to facilitate mechanical ventilation
  • The patient participated in clinical drug trials within the previous 30 days or participated in this clinical trial before or is currently participating in any other clinical trial
  • The patient has a known hypersensitivity to the drugs under investigation or to propofol (and other components of the preparation to be used), soy and peanut
  • For female patients: the patient is pregnant or breastfeeding
  • The patient is classified as ASA V or moribund
  • The patient must be expected to show an impaired cerebral or neurologic capacity due to illness, trauma or other interventions, which will interfere with the collection of the analgesia/sedation scores and the waking behavior as for example, without being limited to:
  • Hypoxic brain damage
  • Cerebrocranial trauma grades II, III, and IV
  • Subarachnoid hemorrhage, brain-stem hemorrhage, ischemic-hemorrhagic cerebral hemorrhages
  • Amyotrophic lateral sclerosis, myasthenia gravis
  • Stupor or coma
  • The patient requires chronic ventilation
  • The patient is receiving chronic (\> 3 months) therapy with high-potency opioids/WHO level 3
  • The patient is alcohol or drug dependent (legal or illegal drugs in particular, but not exclusively with dependency on sedatives or benzodiazepines), defined as:
  • Typically an urgent desire to take the substance, problems in controlling consumption, and persistent use of the substance despite adverse consequences. The use of the substance has priority over other activities and responsibilities. Developing increased tolerance and occasionally physical withdrawal symptom.
  • The patient suffers from a manifest organ failure
  • The patient suffers from severe heart failure, NYHA Class IV (symptoms at rest)
  • The patient has a history of or actually suffers from ventricular tachycardia, ventricular flutter or ventricular fibrillation

Exclusion

    Key Trial Info

    Start Date :

    January 1 2007

    Trial Type :

    INTERVENTIONAL

    End Date :

    Estimated Enrollment :

    164 Patients enrolled

    Trial Details

    Trial ID

    NCT00421720

    Start Date

    January 1 2007

    Last Update

    April 3 2018

    Active Locations (10)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (10 locations)

    1

    GSK Clinical Trials Call Center

    Bonn, Germany, 53105

    2

    GSK Clinical Trials Call Center

    Dresden, Germany, 01067

    3

    GSK Clinical Trials Call Center

    Heidelberg, Germany, 69120

    4

    GSK Clinical Trials Call Center

    Homburg/Saar, Germany, 66421