AnalgesiaPhase 4NCT00421720
A Study Comparing Two Analgesia/Sedation Regimens, Remifentanil/Propofol Versus Sufentanil/Propofol In Mechanically Ventilated Intensive Care Patients Requiring Analgesia And Sedation.
A Phase 4 study testing Sufentanil and Remifentanil in people with Analgesia and Sedation, run by GlaxoSmithKline at 10 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Sufentanil and Remifentanil
- How many people
- 164 participants
- Where
- 10 sitesGermany
- Study dates
- Jan 2007to not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
GSK Clinical Trials Call Center
Bonn, 53105
GSK Clinical Trials Call Center
Dresden, 01067
GSK Clinical Trials Call Center
Heidelberg, 69120
GSK Clinical Trials Call Center
Homburg/Saar, 66421
GSK Clinical Trials Call Center
Kiel, 24105
GSK Clinical Trials Call Center
Ludwigshafen, 67063
GSK Clinical Trials Call Center
Rostock, 18057
GSK Clinical Trials Call Center
Saarbrücken, 66119
GSK Clinical Trials Call Center
Schwerin, 19049
GSK Clinical Trials Call Center
Tübingen, 72076
About this study
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
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.
Read more
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.
- Being tested
- Sufentanil, Remifentanil
- Keywords
- remifentanil, sufentanil, propofol, analgesia, sedation, mechanically ventilated, intensive care, pharmacoeconomic, weaning, delirium, randomized, Germany
- Medical subject headings
- Agnosia, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SufentanilDrug
RemifentanilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2007 (estimated)
- Study startJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, MD, PhD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421720
- Sponsor's protocol ID
- USA107212
- Other IDs
- EudraCT: 2006-001276-20
- Status last verified
- Mar 2018
- First submitted
- 11 Jan 2007
- Last updated
- 3 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00421720
- Acronym / sponsor ID
- USA107212
- Keywords
- remifentanil, sufentanil, propofol, analgesia, sedation, mechanically ventilated, intensive care, pharmacoeconomic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 164 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- First posted
- 12 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sufentanil | Drug | – |
| Remifentanil | Drug | – |
Primary outcome
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")
1 secondary outcome
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials, MD, PhD study director
GlaxoSmithKline
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sufentanil and Remifentanil in people with Analgesia and Sedation, run by GlaxoSmithKline at 10 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2018.