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

This study has been terminated.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00421720
First received: January 11, 2007
Last updated: July 24, 2007
Last verified: July 2007
  Purpose

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 intensive care patients in terms of efficacy, safety and resource utilization.

The special characteristics of intensive care patients (organ insufficiencies etc.) regularly cause an accumulation of the analgesics, sedatives and adjuvants used. Clinically, this complicates the calculation of weaning and extubation times, often making mechanical ventilation necessary for longer periods than desired and also extending the stay of patients in the intensive care unit. Reducing weaning times and the duration of intensive care treatment by optimizing analgesia/sedation could furthermore lead to a reduction in typical complications such as ventilator-associated pneumonia or delirium.

The demands on an ideal analgesic are analgesic efficacy without severe cardiopulmonary depression and rapid onset of effect and in particular a short dura-tion of effect and absence of accumulation or development of active metabolites. Remifentanil is an ultra-short acting µ-agonist which is, due to its molecular structure, metabolized organ-independently by unspecific blood and tissue esterases with the substance being degraded within only a few minutes and the resulting metabolites being virtually ineffective at the µ-receptor. Sufentanil, on the other hand, is mainly metabolized by the cytochrome P-450-3A4 enzyme in the liver and small intestine.

To date, only one study with a small sample size is available on the comparison of the effectiveness and safety of remifentanil and sufentanil when used for long-term analgesia/sedation.


Condition Intervention Phase
Analgesia
Sedation
Drug: Sufentanil
Drug: Remifentanil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Multicenter, Parallel-Group Study to Compare the Efficacy, Safety and Resource Utilization of a Remifentanil/Propofol Analgesia/Sedation Regimen Versus a Sufentanil/Propofol Analgesia/Sedation Regimen in Mechanically Ventilated Intensive Care Patients Requiring Analgesia and Sedation for up to 7 Days

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Comparison of ventilation and weaning times: - Time from initiation of analgesia/sedation using the investigational substance and extubation ("ventilation time") - Time from the start of weaning to extubation ("weaning time")

Secondary Outcome Measures:
  • ICU length of stay; accuracy of analgesia/sedation; drug consumption of analgesics/sedatives; clinical course; incidence of pneumonia/delirium; infection markers; bowel movement; ventilation parameters; vital signs; resource utilization; safety

Estimated Enrollment: 164
Study Start Date: January 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421720

Locations
Germany
GSK Clinical Trials Call Center
Bonn, Germany, 53105
GSK Clinical Trials Call Center
Dresden, Germany, 01067
GSK Clinical Trials Call Center
Heidelberg, Germany, 69120
GSK Clinical Trials Call Center
Homburg/Saar, Germany, 66421
GSK Clinical Trials Call Center
Kiel, Germany, 24105
GSK Clinical Trials Call Center
Ludwigshafen, Germany, 67063
GSK Clinical Trials Call Center
Rostock, Germany, 18057
GSK Clinical Trials Call Center
Saarbrucken, Germany, 66119
GSK Clinical Trials Call Center
Schwerin, Germany, 19049
GSK Clinical Trials Call Center
Tubingen, Germany, 72076
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD, PhD GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00421720     History of Changes
Other Study ID Numbers: USA107212, EudraCT: 2006-001276-20
Study First Received: January 11, 2007
Last Updated: July 24, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
remifentanil
sufentanil
propofol
analgesia
sedation
mechanically ventilated
intensive care
pharmacoeconomic
weaning
delirium
randomized
Germany

Additional relevant MeSH terms:
Propofol
Remifentanil
Sufentanil
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Narcotics

ClinicalTrials.gov processed this record on July 22, 2014