NCT00421720|TerminatedPhase 4

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

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

GlaxoSmithKline ClinicalTrials.gov

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2 other identifiers

USA107212EudraCT: 2006-001276-20

Study Type

interventional

Target

164

Locations

1 country

Sites

Timeline

RegisteredJan 2007

StartedJan 2007

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 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.

Trial Health

At Risk

Trial Health Score

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

Enrollment

164

participants targeted

Target at P50-P75 for phase_4

Geographic Reach

1 country

10 active sites

Status

terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed

10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2007

Completed

Last Updated

April 3, 2018

Status Verified

March 1, 2018

First QC Date

January 11, 2007

Last Update Submit

March 30, 2018

Conditions

Analgesia Sedation

Keywords

remifentanilsufentanilpropofolanalgesiasedationmechanically ventilatedintensive carepharmacoeconomicweaningdeliriumrandomizedGermany

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

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

Interventions

SufentanilDRUG

RemifentanilDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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
+6 more criteria

Contact the study team to confirm eligibility.